Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT), Regional Citrate Anticoagulation (RCA)
Conditions
Keywords
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury
Brief summary
The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.
Interventions
DRUGPrismocitrate 18
Modality of CVVHDF
OTHERNo Anticoagulation
Modality of CVVHDF
Sponsors
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must be receiving medical care in an intensive care unit (ICU) (e.g., medical ICU, surgical ICU, cardiothoracic ICU, Trauma ICU, Mixed ICU, other). 2. Adult patients with AKI or other serious conditions who require treatment with CRRT. 3. Patients are expected to remain in the ICU and on CRRT for at least 72 hours after randomization. 4. Patients already receiving standard-of-care CRRT must be randomized within 24 hours of initiation of their standard-of-care CRRT.
Exclusion criteria
1. Patients requiring systemic anticoagulation with antithrombotic agents for reasons other than CRRT. The exception is patients receiving subcutaneous heparin for deep vein thrombosis prophylaxis according to institutional practice or patients on aspirin may be enrolled. 2. Patients in whom citrate anticoagulation is contraindicated such as patients with a known allergy to citrate or who have experienced adverse events associated with citrate products including patients with a prior history of citrate toxicity or patients with uncorrected severe hypocalcemia (whether in the context of current citrate administration or due to the underlying disease state). 3. Patients who are not candidates for CRRT. 4. Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy. 5. Patients with severe coagulopathy \[i.e., platelets \< 30,000/mm3, international normalized ratio (INR) \> 2, partial thromboplastin time (PTT) \> 50 seconds\] including severe thrombocytopenia (platelets \< 30,000/mm3), HIT (heparin induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), and TTP (thrombotic thrombocytopenia purpura) should not be enrolled in the trial. 6. Patients with fulminant acute liver failure or acute on chronic liver failure as documented by a Child-Pugh Liver Failure Score \> 10. 7. Patients with refractory shock associated persistent, worsening with lactic acidosis (lactate \> 4 mmol/L). However, patients with improving subsequent serum lactate levels may be enrolled. 8. Patients unlikely to survive at least 72 hours. 9. Female patients who are pregnant, lactating, or planning to become pregnant during the study period. 10. Patients who are currently participating in another interventional clinical study. 11. Patients with a medical condition that may interfere with the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | Up to 120 hours post CRRT treatment initiation | The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) Warning: Filter Clotted, and/or (2) Advisory transmembrane pressure (TMP) Too High. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in pH by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Base Excess by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Blood Total Calcium Concentration by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Temperature at Last Visit | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Pulse at Last Visit | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Patient Ionized Calcium (iCa) by Hour | Baseline and up to 120 hours post CRRT treatment initiation | Systemic blood iCa concentrations |
| Extracorporeal Circuit Ionized Calcium by Hour | Up to 120 hours post CRRT treatment initiation | Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter). |
| Delivery of Prescribed CRRT Dose by Day | Up to 120 hours post CRRT treatment initiation | Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour. |
| Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment | Prior to study use of Prismocitrate 18 | Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training. The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period. The training assessment was housed on a restricted access study website. Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment. |
| Change From Baseline in Serum Sodium by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Serum Anion Gap by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Serum Bicarbonate by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Serum Phosphate by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Serum Potassium by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Serum Chloride by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Number of Participants With Bleeding Events | Up to 120 hours post CRRT treatment initiation | — |
| Number of Participants by Number of Blood Transfusions | Up to 120 hours post CRRT treatment initiation | — |
| Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious) | Up to 30 days post study CRRT treatment completion | — |
| Change From Baseline in Blood Pressure at Last Visit | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Respiratory Rate at Last Visit | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Total Calcium/iCa Ratio by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
| Number of Bleeding Events by Location | Up to 120 hours post CRRT treatment initiation | — |
| Duration of Bleeding Events | Up to 120 hours post CRRT treatment initiation | — |
| Change From Baseline in Serum Magnesium by Hour | Baseline and up to 120 hours post CRRT treatment initiation | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prismocitrate 18 CRRT with Prismocitrate 18 solution. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | 17 |
| No Systemic Anticoagulation CRRT with no systemic anticoagulation. If a patient was already receiving standard-of-care CRRT, they were required to be randomized within 24 hours of initiation of their standard-of-care CRRT. All patients were treated with pre-dilution CVVHDF as the study CRRT modality. Extracorporeal circuit life was monitored for up to 120 hours of study CRRT (Treatment Period). | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | No Systemic Anticoagulation | Prismocitrate 18 | Total |
|---|---|---|---|
| Age, Customized ≥ 18 years to ≤ 35 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized > 35 years to ≤ 45 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized > 45 years to ≤ 55 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Customized > 55 years to ≤ 65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Customized > 65 years | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 15 Participants | 24 Participants |
| Region of Enrollment United States | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 17 | 9 / 17 |
| other Total, other adverse events | 13 / 17 | 14 / 17 |
| serious Total, serious adverse events | 10 / 17 | 10 / 17 |
Outcome results
Primary
Time to Occurrence of Selected Prismaflex® System Alarms/Conditions
The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e. number surviving divided by number at risk), based on the Kaplan-Meier method. For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving. Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints. The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient. The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) Warning: Filter Clotted, and/or (2) Advisory transmembrane pressure (TMP) Too High.
Time frame: Up to 120 hours post CRRT treatment initiation
Population: Full Analysis Set (FAS)-randomized treatment groups (intent-to-treat principle)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prismocitrate 18 | Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | 25 Percentile | 33.180 hours |
| Prismocitrate 18 | Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | 50 Percentile | NA hours |
| Prismocitrate 18 | Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | 75 Percentile | NA hours |
| No Systemic Anticoagulation | Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | 25 Percentile | 17.680 hours |
| No Systemic Anticoagulation | Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | 50 Percentile | 29.660 hours |
| No Systemic Anticoagulation | Time to Occurrence of Selected Prismaflex® System Alarms/Conditions | 75 Percentile | NA hours |
Secondary
Change From Baseline in Base Excess by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 6 Hours | 0.4 mmol/L | Standard Deviation 6.92 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 12 Hours | -1.3 mmol/L | Standard Deviation 5.06 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 18 Hours | 0.3 mmol/L | Standard Deviation 7.28 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 24 Hours | 2.4 mmol/L | Standard Deviation 6.65 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 30 Hours | 1.3 mmol/L | Standard Deviation 5.64 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 36 Hours | 3 mmol/L | Standard Deviation 7.36 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 42 Hours | 2.8 mmol/L | Standard Deviation 7.41 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 48 Hours | 2.4 mmol/L | Standard Deviation 6.87 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 54 Hours | 1.3 mmol/L | Standard Deviation 6.99 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 60 Hours | 3.7 mmol/L | Standard Deviation 7.57 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 66 Hours | 3.2 mmol/L | Standard Deviation 8.43 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 72 Hours | 3.6 mmol/L | Standard Deviation 7.5 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 78 Hours | 2.5 mmol/L | Standard Deviation 5.77 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 84 Hours | 4 mmol/L | Standard Deviation 6.61 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 90 Hours | 3 mmol/L | Standard Deviation 5.98 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 96 Hours | 3.5 mmol/L | Standard Deviation 7.29 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 102 Hours | 1.6 mmol/L | Standard Deviation 5.56 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 108 Hours | 3.5 mmol/L | Standard Deviation 5.95 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 114 Hours | 2.7 mmol/L | Standard Deviation 5.72 |
| Prismocitrate 18 | Change From Baseline in Base Excess by Hour | 120 Hours | 2.8 mmol/L | Standard Deviation 7.23 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 108 Hours | 0.8 mmol/L | Standard Deviation 9.34 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 6 Hours | 1.1 mmol/L | Standard Deviation 4.72 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 66 Hours | 2.1 mmol/L | Standard Deviation 5.2 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 12 Hours | 1.7 mmol/L | Standard Deviation 4.75 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 96 Hours | 2.2 mmol/L | Standard Deviation 5.91 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 18 Hours | 1.1 mmol/L | Standard Deviation 6.08 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 72 Hours | -2.1 mmol/L | Standard Deviation 12.94 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 24 Hours | 0.6 mmol/L | Standard Deviation 6.15 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 120 Hours | -2.0 mmol/L | Standard Deviation 8.94 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 30 Hours | 1.7 mmol/L | Standard Deviation 5.91 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 78 Hours | 4 mmol/L | Standard Deviation 5.98 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 36 Hours | 0.9 mmol/L | Standard Deviation 5.74 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 102 Hours | -1.0 mmol/L | Standard Deviation 9.04 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 42 Hours | 2.1 mmol/L | Standard Deviation 6.09 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 84 Hours | 3.7 mmol/L | Standard Deviation 5.27 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 48 Hours | 1.9 mmol/L | Standard Deviation 5.67 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 114 Hours | -2.8 mmol/L | Standard Deviation 9.47 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 54 Hours | 0.4 mmol/L | Standard Deviation 5.78 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 90 Hours | 3.1 mmol/L | Standard Deviation 5.53 |
| No Systemic Anticoagulation | Change From Baseline in Base Excess by Hour | 60 Hours | 1.2 mmol/L | Standard Deviation 7.26 |
Secondary
Change From Baseline in Blood Pressure at Last Visit
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Blood Pressure at Last Visit | Systolic | 1.9 mmHg | Standard Deviation 25.37 |
| Prismocitrate 18 | Change From Baseline in Blood Pressure at Last Visit | Diastolic | -2.8 mmHg | Standard Deviation 12.29 |
| No Systemic Anticoagulation | Change From Baseline in Blood Pressure at Last Visit | Systolic | -6.4 mmHg | Standard Deviation 30.99 |
| No Systemic Anticoagulation | Change From Baseline in Blood Pressure at Last Visit | Diastolic | 2.8 mmHg | Standard Deviation 21.19 |
Secondary
Change From Baseline in Blood Total Calcium Concentration by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 1 Hour | -0.0 mmol/L | Standard Deviation 0.12 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 6 Hours | 0.1 mmol/L | Standard Deviation 0.21 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 12 Hours | 0.2 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 18 Hours | 0.2 mmol/L | Standard Deviation 0.25 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 24 Hours | 0.3 mmol/L | Standard Deviation 0.24 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 30 Hours | 0.3 mmol/L | Standard Deviation 0.22 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 36 Hours | 0.3 mmol/L | Standard Deviation 0.24 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 42 Hours | 0.3 mmol/L | Standard Deviation 0.28 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 48 Hours | 0.3 mmol/L | Standard Deviation 0.26 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 54 Hours | 0.3 mmol/L | Standard Deviation 0.24 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 60 Hours | 0.3 mmol/L | Standard Deviation 0.24 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 66 Hours | 0.3 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 72 Hours | 0.3 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 78 Hours | 0.3 mmol/L | Standard Deviation 0.29 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 84 Hours | 0.3 mmol/L | Standard Deviation 0.33 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 90 Hours | 0.3 mmol/L | Standard Deviation 0.35 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 96 Hours | 0.2 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 102 Hours | 0.2 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 108 Hours | 0.3 mmol/L | Standard Deviation 0.35 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 114 Hours | 0.2 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Blood Total Calcium Concentration by Hour | 120 Hours | 0.4 mmol/L | Standard Deviation 0.2 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 60 Hours | -0.1 mmol/L | Standard Deviation 0.24 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 1 Hour | -0.0 mmol/L | Standard Deviation 0.13 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 108 Hours | -0.1 mmol/L | Standard Deviation 0.29 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 6 Hours | -0.0 mmol/L | Standard Deviation 0.14 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 66 Hours | -0.1 mmol/L | Standard Deviation 0.26 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 12 Hours | -0.0 mmol/L | Standard Deviation 0.19 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 96 Hours | -0.2 mmol/L | Standard Deviation 0.27 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 18 Hours | -0.0 mmol/L | Standard Deviation 0.22 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 72 Hours | -0.1 mmol/L | Standard Deviation 0.26 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 24 Hours | -0.1 mmol/L | Standard Deviation 0.31 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 120 Hours | -0.1 mmol/L | Standard Deviation 0.24 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 30 Hours | -0.0 mmol/L | Standard Deviation 0.22 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 78 Hours | -0.1 mmol/L | Standard Deviation 0.24 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 36 Hours | -0.1 mmol/L | Standard Deviation 0.24 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 102 Hours | -0.1 mmol/L | Standard Deviation 0.29 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 42 Hours | -0.1 mmol/L | Standard Deviation 0.22 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 84 Hours | -0.2 mmol/L | Standard Deviation 0.27 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 48 Hours | -0.1 mmol/L | Standard Deviation 0.27 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 114 Hours | -0.2 mmol/L | Standard Deviation 0.25 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 54 Hours | -0.1 mmol/L | Standard Deviation 0.25 |
| No Systemic Anticoagulation | Change From Baseline in Blood Total Calcium Concentration by Hour | 90 Hours | -0.1 mmol/L | Standard Deviation 0.27 |
Secondary
Change From Baseline in Patient Ionized Calcium (iCa) by Hour
Systemic blood iCa concentrations
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 78 Hours | 0 mmol/L | Standard Deviation 0.16 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 72 Hours | 0 mmol/L | Standard Deviation 0.13 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 1 Hour | -0.1 mmol/L | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 6 Hours | -0.1 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 12 Hours | -0.0 mmol/L | Standard Deviation 0.17 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 18 Hours | 0 mmol/L | Standard Deviation 0.18 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 24 Hours | 0.1 mmol/L | Standard Deviation 0.19 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 30 Hours | 0 mmol/L | Standard Deviation 0.17 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 36 Hours | 0 mmol/L | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 42 Hours | 0 mmol/L | Standard Deviation 0.18 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 48 Hours | 0 mmol/L | Standard Deviation 0.15 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 54 hours | 0 mmol/L | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 60 hours | 0 mmol/L | Standard Deviation 0.12 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 66 Hours | -0.0 mmol/L | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 84 Hours | 0 mmol/L | Standard Deviation 0.15 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 90 Hours | 0 mmol/L | Standard Deviation 0.17 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 96 Hours | 0 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 102 Hours | 0 mmol/L | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 108 Hours | 0 mmol/L | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 114 Hours | 0.1 mmol/L | Standard Deviation 0.13 |
| Prismocitrate 18 | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 120 Hours | 0.1 mmol/L | Standard Deviation 0.14 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 48 Hours | 0 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 66 Hours | -0.0 mmol/L | Standard Deviation 0.15 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 108 Hours | 0 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 72 Hours | 0 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 54 hours | -0.0 mmol/L | Standard Deviation 0.15 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 1 Hour | 0 mmol/L | Standard Deviation 0.06 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 96 Hours | -0.0 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 6 Hours | 0 mmol/L | Standard Deviation 0.07 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 60 hours | -0.0 mmol/L | Standard Deviation 0.15 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 12 Hours | 0 mmol/L | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 120 Hours | -0.0 mmol/L | Standard Deviation 0.15 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 18 Hours | 0 mmol/L | Standard Deviation 0.12 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 78 Hours | 0 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 24 Hours | -0.0 mmol/L | Standard Deviation 0.17 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 102 Hours | 0 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 30 Hours | 0 mmol/L | Standard Deviation 0.13 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 84 Hours | -0.0 mmol/L | Standard Deviation 0.17 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 36 Hours | -0.0 mmol/L | Standard Deviation 0.12 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 114 Hours | 0 mmol/L | Standard Deviation 0.15 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 42 Hours | 0 mmol/L | Standard Deviation 0.15 |
| No Systemic Anticoagulation | Change From Baseline in Patient Ionized Calcium (iCa) by Hour | 90 Hours | -0.0 mmol/L | Standard Deviation 0.15 |
Secondary
Change From Baseline in pH by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in pH by Hour | 18 Hours | 0 pH | Standard Deviation 0.1 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 66 Hours | 0.1 pH | Standard Deviation 0.16 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 36 Hours | 0 pH | Standard Deviation 0.11 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 72 Hours | 0 pH | Standard Deviation 0.13 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 12 Hours | -0.0 pH | Standard Deviation 0.07 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 78 Hours | 0 pH | Standard Deviation 0.13 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 42 Hours | 0 pH | Standard Deviation 0.11 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 84 Hours | 0.1 pH | Standard Deviation 0.12 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 24 Hours | 0 pH | Standard Deviation 0.1 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 90 Hours | 0 pH | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 48 Hours | 0 pH | Standard Deviation 0.12 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 96 Hours | 0 pH | Standard Deviation 0.16 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 6 Hours | -0.0 pH | Standard Deviation 0.06 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 54 Hours | 0 pH | Standard Deviation 0.13 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 108 Hours | 0 pH | Standard Deviation 0.11 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 30 Hours | 0 pH | Standard Deviation 0.1 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 114 Hours | 0 pH | Standard Deviation 0.12 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 60 Hours | 0 pH | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 120 Hours | -0.0 pH | Standard Deviation 0.12 |
| Prismocitrate 18 | Change From Baseline in pH by Hour | 102 Hours | 0 pH | Standard Deviation 0.12 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 120 Hours | 0 pH | Standard Deviation 0.17 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 6 Hours | 0.1 pH | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 12 Hours | 0.1 pH | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 18 Hours | 0 pH | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 24 Hours | 0 pH | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 30 Hours | 0.1 pH | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 36 Hours | 0.1 pH | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 42 Hours | 0.1 pH | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 48 Hours | 0.1 pH | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 54 Hours | 0.1 pH | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 60 Hours | 0.1 pH | Standard Deviation 0.08 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 66 Hours | 0 pH | Standard Deviation 0.07 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 72 Hours | 0 pH | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 78 Hours | 0.1 pH | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 84 Hours | 0.1 pH | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 90 Hours | 0.1 pH | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 96 Hours | 0.1 pH | Standard Deviation 0.14 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 102 Hours | 0 pH | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 108 Hours | 0.1 pH | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in pH by Hour | 114 Hours | -0.0 pH | Standard Deviation 0.12 |
Secondary
Change From Baseline in Pulse at Last Visit
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Pulse at Last Visit | 2.1 beats/min | Standard Deviation 24.66 |
| No Systemic Anticoagulation | Change From Baseline in Pulse at Last Visit | 3.2 beats/min | Standard Deviation 16.52 |
Secondary
Change From Baseline in Respiratory Rate at Last Visit
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Respiratory Rate at Last Visit | -2.1 breaths/Min | Standard Deviation 5.42 |
| No Systemic Anticoagulation | Change From Baseline in Respiratory Rate at Last Visit | -1.1 breaths/Min | Standard Deviation 7.64 |
Secondary
Change From Baseline in Serum Anion Gap by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 6 Hours | 0.6 mmol/L | Standard Deviation 3.08 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 12 Hours | 0.6 mmol/L | Standard Deviation 2.45 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 18 Hours | 0.2 mmol/L | Standard Deviation 2.96 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 24 Hours | -0.5 mmol/L | Standard Deviation 3.07 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 30 Hours | 1.6 mmol/L | Standard Deviation 3.08 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 36 Hours | 0.5 mmol/L | Standard Deviation 3.41 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 42 Hours | 0.7 mmol/L | Standard Deviation 3.33 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 48 Hours | 0.7 mmol/L | Standard Deviation 3.7 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 54 Hours | 0.3 mmol/L | Standard Deviation 3.47 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 60 Hours | 0.4 mmol/L | Standard Deviation 3.58 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 66 Hours | 1.1 mmol/L | Standard Deviation 4 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 72 Hours | 1 mmol/L | Standard Deviation 4.37 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 78 Hours | 0.7 mmol/L | Standard Deviation 2.39 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 84 Hours | 0.8 mmol/L | Standard Deviation 2.74 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 90 Hours | 0.8 mmol/L | Standard Deviation 3.59 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 96 Hours | 1.6 mmol/L | Standard Deviation 2.35 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 102 Hours | 1.5 mmol/L | Standard Deviation 2.54 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 108 Hours | 0.8 mmol/L | Standard Deviation 2.67 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 114 Hours | 1 mmol/L | Standard Deviation 2.71 |
| Prismocitrate 18 | Change From Baseline in Serum Anion Gap by Hour | 120 Hours | -0.3 mmol/L | Standard Deviation 2.06 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 108 Hours | 0.6 mmol/L | Standard Deviation 5.44 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 6 Hours | -2.3 mmol/L | Standard Deviation 2.27 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 66 Hours | -3.2 mmol/L | Standard Deviation 4.37 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 12 Hours | -3.5 mmol/L | Standard Deviation 3.1 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 96 Hours | -1.7 mmol/L | Standard Deviation 4.21 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 18 Hours | -2.2 mmol/L | Standard Deviation 4.72 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 72 Hours | 0 mmol/L | Standard Deviation 5.93 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 24 Hours | -2.9 mmol/L | Standard Deviation 3.24 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 120 Hours | -1.2 mmol/L | Standard Deviation 7.03 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 30 Hours | -3.6 mmol/L | Standard Deviation 3.55 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 78 Hours | -2.0 mmol/L | Standard Deviation 3.4 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 36 Hours | -4 mmol/L | Standard Deviation 2.73 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 102 Hours | -1.7 mmol/L | Standard Deviation 5.15 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 42 Hours | -3.5 mmol/L | Standard Deviation 2.9 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 84 Hours | -3.0 mmol/L | Standard Deviation 3.91 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 48 Hours | -2.8 mmol/L | Standard Deviation 3.21 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 114 Hours | 0.7 mmol/L | Standard Deviation 8.64 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 54 Hours | -3.2 mmol/L | Standard Deviation 3.27 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 90 Hours | -2.1 mmol/L | Standard Deviation 3.54 |
| No Systemic Anticoagulation | Change From Baseline in Serum Anion Gap by Hour | 60 Hours | -2.3 mmol/L | Standard Deviation 3.67 |
Secondary
Change From Baseline in Serum Bicarbonate by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 6 Hours | 0.2 mmol/L | Standard Deviation 3.86 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 12 Hours | 0.8 mmol/L | Standard Deviation 4.42 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 18 Hours | 1.3 mmol/L | Standard Deviation 5.43 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 24 Hours | 2.8 mmol/L | Standard Deviation 4.64 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 30 Hours | 2.9 mmol/L | Standard Deviation 5.02 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 36 Hours | 3.3 mmol/L | Standard Deviation 5.6 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 42 Hours | 3.3 mmol/L | Standard Deviation 5.52 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 48 Hours | 2.7 mmol/L | Standard Deviation 5.56 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 54 Hours | 2.7 mmol/L | Standard Deviation 5.72 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 60 Hours | 4.7 mmol/L | Standard Deviation 6.56 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 66 Hours | 3.7 mmol/L | Standard Deviation 6.49 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 72 Hours | 4.2 mmol/L | Standard Deviation 6.59 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 78 Hours | 2.8 mmol/L | Standard Deviation 5.01 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 84 Hours | 3.3 mmol/L | Standard Deviation 5.48 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 90 Hours | 3.3 mmol/L | Standard Deviation 6.05 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 96 Hours | 2.8 mmol/L | Standard Deviation 5.88 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 102 Hours | 2.2 mmol/L | Standard Deviation 5.64 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 108 Hours | 2.7 mmol/L | Standard Deviation 5.25 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 114 Hours | 3.8 mmol/L | Standard Deviation 6.2 |
| Prismocitrate 18 | Change From Baseline in Serum Bicarbonate by Hour | 120 Hours | 2.8 mmol/L | Standard Deviation 5.94 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 108 Hours | -0.4 mmol/L | Standard Deviation 7.67 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 6 Hours | 2.4 mmol/L | Standard Deviation 3.48 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 66 Hours | 2.6 mmol/L | Standard Deviation 5.02 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 12 Hours | 2.9 mmol/L | Standard Deviation 3.27 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 96 Hours | 1.4 mmol/L | Standard Deviation 5.81 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 18 Hours | 2.3 mmol/L | Standard Deviation 4.11 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 72 Hours | 0.1 mmol/L | Standard Deviation 6.68 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 24 Hours | 2 mmol/L | Standard Deviation 4.99 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 120 Hours | -1.5 mmol/L | Standard Deviation 7.13 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 30 Hours | 2.9 mmol/L | Standard Deviation 4.21 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 78 Hours | 2.9 mmol/L | Standard Deviation 5.46 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 36 Hours | 2.6 mmol/L | Standard Deviation 3.71 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 102 Hours | -1.1 mmol/L | Standard Deviation 7.48 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 42 Hours | 3.6 mmol/L | Standard Deviation 3.61 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 84 Hours | 2.5 mmol/L | Standard Deviation 5.34 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 48 Hours | 2.4 mmol/L | Standard Deviation 3.99 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 114 Hours | -2.8 mmol/L | Standard Deviation 8 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 54 Hours | 2.1 mmol/L | Standard Deviation 3.77 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 90 Hours | 2.2 mmol/L | Standard Deviation 5.26 |
| No Systemic Anticoagulation | Change From Baseline in Serum Bicarbonate by Hour | 60 Hours | 2.4 mmol/L | Standard Deviation 4.29 |
Secondary
Change From Baseline in Serum Chloride by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 6 Hours | -1.9 mmol/L | Standard Deviation 4.12 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 12 Hours | -3.4 mmol/L | Standard Deviation 4.23 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 18 Hours | -3.9 mmol/L | Standard Deviation 5.67 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 24 Hours | -3.9 mmol/L | Standard Deviation 6.58 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 30 Hours | -5.5 mmol/L | Standard Deviation 6.84 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 36 Hours | -5.0 mmol/L | Standard Deviation 6.73 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 42 Hours | -4.9 mmol/L | Standard Deviation 7.31 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 48 Hours | -5.1 mmol/L | Standard Deviation 7.35 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 54 Hours | -5.4 mmol/L | Standard Deviation 7.39 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 60 Hours | -5.9 mmol/L | Standard Deviation 7.68 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 66 Hours | -5.3 mmol/L | Standard Deviation 7.82 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 72 Hours | -5.6 mmol/L | Standard Deviation 7.61 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 78 Hours | -5.5 mmol/L | Standard Deviation 7.4 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 84 Hours | -5.8 mmol/L | Standard Deviation 6.76 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 90 Hours | -5.9 mmol/L | Standard Deviation 7.68 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 96 Hours | -6.2 mmol/L | Standard Deviation 7.69 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 102 Hours | -6.0 mmol/L | Standard Deviation 7.51 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 108 Hours | -5.9 mmol/L | Standard Deviation 7.88 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 114 Hours | -7.7 mmol/L | Standard Deviation 8.63 |
| Prismocitrate 18 | Change From Baseline in Serum Chloride by Hour | 120 Hours | -8.1 mmol/L | Standard Deviation 6.28 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 108 Hours | 1.3 mmol/L | Standard Deviation 4.42 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 6 Hours | 0.6 mmol/L | Standard Deviation 3.1 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 66 Hours | 1 mmol/L | Standard Deviation 4.94 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 12 Hours | 0.9 mmol/L | Standard Deviation 3.44 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 96 Hours | 2.4 mmol/L | Standard Deviation 4.64 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 18 Hours | 0.8 mmol/L | Standard Deviation 3.52 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 72 Hours | 1.7 mmol/L | Standard Deviation 4.38 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 24 Hours | 1.3 mmol/L | Standard Deviation 5.04 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 120 Hours | 1 mmol/L | Standard Deviation 5.89 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 30 Hours | 1.1 mmol/L | Standard Deviation 4.59 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 78 Hours | 2.4 mmol/L | Standard Deviation 4.45 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 36 Hours | 0.6 mmol/L | Standard Deviation 4.44 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 102 Hours | 2.6 mmol/L | Standard Deviation 6.02 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 42 Hours | 0.5 mmol/L | Standard Deviation 4.5 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 84 Hours | 2.1 mmol/L | Standard Deviation 5.33 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 48 Hours | 1.3 mmol/L | Standard Deviation 4.44 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 114 Hours | 1.1 mmol/L | Standard Deviation 5.96 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 54 Hours | 0.9 mmol/L | Standard Deviation 4.91 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 90 Hours | 2.3 mmol/L | Standard Deviation 5.1 |
| No Systemic Anticoagulation | Change From Baseline in Serum Chloride by Hour | 60 Hours | 1 mmol/L | Standard Deviation 4.79 |
Secondary
Change From Baseline in Serum Magnesium by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 6 Hours | -0.1 mmol/L | Standard Deviation 0.12 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 12 Hours | -0.1 mmol/L | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 18 Hours | -0.1 mmol/L | Standard Deviation 0.19 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 24 Hours | -0.2 mmol/L | Standard Deviation 0.2 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 30 Hours | -0.1 mmol/L | Standard Deviation 0.23 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 36 Hours | -0.1 mmol/L | Standard Deviation 0.22 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 42 Hours | -0.2 mmol/L | Standard Deviation 0.23 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 48 Hours | -0.2 mmol/L | Standard Deviation 0.25 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 54 Hours | -0.2 mmol/L | Standard Deviation 0.21 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 60 Hours | -0.1 mmol/L | Standard Deviation 0.23 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 66 Hours | -0.1 mmol/L | Standard Deviation 0.24 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 72 Hours | -0.1 mmol/L | Standard Deviation 0.22 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 78 Hours | -0.2 mmol/L | Standard Deviation 0.21 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 84 Hours | -0.2 mmol/L | Standard Deviation 0.22 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 90 Hours | -0.2 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 96 Hours | -0.2 mmol/L | Standard Deviation 0.24 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 102 Hours | -0.2 mmol/L | Standard Deviation 0.23 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 108 Hours | -0.2 mmol/L | Standard Deviation 0.28 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 114 Hours | -0.1 mmol/L | Standard Deviation 0.27 |
| Prismocitrate 18 | Change From Baseline in Serum Magnesium by Hour | 120 Hours | -0.2 mmol/L | Standard Deviation 0.28 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 108 Hours | 0.1 mmol/L | Standard Deviation 0.2 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 6 Hours | 0 mmol/L | Standard Deviation 0.14 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 66 Hours | 0 mmol/L | Standard Deviation 0.18 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 12 Hours | -0.0 mmol/L | Standard Deviation 0.14 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 96 Hours | 0.1 mmol/L | Standard Deviation 0.18 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 18 Hours | 0 mmol/L | Standard Deviation 0.14 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 72 Hours | 0.1 mmol/L | Standard Deviation 0.2 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 24 Hours | -0.0 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 120 Hours | 0 mmol/L | Standard Deviation 0.21 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 30 Hours | 0 mmol/L | Standard Deviation 0.17 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 78 Hours | 0.1 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 36 Hours | 0 mmol/L | Standard Deviation 0.19 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 102 Hours | 0.1 mmol/L | Standard Deviation 0.2 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 42 Hours | 0 mmol/L | Standard Deviation 0.2 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 84 Hours | 0 mmol/L | Standard Deviation 0.18 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 48 Hours | 0.1 mmol/L | Standard Deviation 0.16 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 114 Hours | 0.1 mmol/L | Standard Deviation 0.23 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 54 Hours | 0 mmol/L | Standard Deviation 0.2 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 90 Hours | 0.1 mmol/L | Standard Deviation 0.21 |
| No Systemic Anticoagulation | Change From Baseline in Serum Magnesium by Hour | 60 Hours | 0 mmol/L | Standard Deviation 0.2 |
Secondary
Change From Baseline in Serum Phosphate by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 6 Hours | -0.3 mmol/L | Standard Deviation 0.33 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 12 Hours | -0.3 mmol/L | Standard Deviation 0.51 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 18 Hours | -0.5 mmol/L | Standard Deviation 0.7 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 24 Hours | -0.7 mmol/L | Standard Deviation 0.74 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 30 Hours | -0.6 mmol/L | Standard Deviation 0.7 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 36 Hours | -0.7 mmol/L | Standard Deviation 0.78 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 42 Hours | -0.8 mmol/L | Standard Deviation 0.82 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 48 Hours | -0.9 mmol/L | Standard Deviation 0.87 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 54 Hours | -0.8 mmol/L | Standard Deviation 0.86 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 60 Hours | -0.9 mmol/L | Standard Deviation 0.93 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 66 Hours | -0.8 mmol/L | Standard Deviation 0.89 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 72 Hours | -0.8 mmol/L | Standard Deviation 0.88 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 78 Hours | -0.8 mmol/L | Standard Deviation 0.86 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 84 Hours | -0.8 mmol/L | Standard Deviation 0.84 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 90 Hours | -0.8 mmol/L | Standard Deviation 0.84 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 96 Hours | -0.8 mmol/L | Standard Deviation 0.92 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 102 Hours | -0.7 mmol/L | Standard Deviation 0.85 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 108 Hours | -0.8 mmol/L | Standard Deviation 0.84 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 114 Hours | -0.9 mmol/L | Standard Deviation 0.91 |
| Prismocitrate 18 | Change From Baseline in Serum Phosphate by Hour | 120 Hours | -0.8 mmol/L | Standard Deviation 1.02 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 108 Hours | -0.4 mmol/L | Standard Deviation 0.76 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 6 Hours | -0.4 mmol/L | Standard Deviation 0.29 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 66 Hours | -0.4 mmol/L | Standard Deviation 0.52 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 12 Hours | -0.4 mmol/L | Standard Deviation 0.32 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 96 Hours | -0.5 mmol/L | Standard Deviation 0.6 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 18 Hours | -0.4 mmol/L | Standard Deviation 0.41 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 72 Hours | -0.2 mmol/L | Standard Deviation 0.74 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 24 Hours | -0.4 mmol/L | Standard Deviation 0.36 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 120 Hours | -0.2 mmol/L | Standard Deviation 0.86 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 30 Hours | -0.5 mmol/L | Standard Deviation 0.35 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 78 Hours | -0.4 mmol/L | Standard Deviation 0.55 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 36 Hours | -0.4 mmol/L | Standard Deviation 0.32 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 102 Hours | -0.4 mmol/L | Standard Deviation 0.63 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 42 Hours | -0.5 mmol/L | Standard Deviation 0.32 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 84 Hours | -0.4 mmol/L | Standard Deviation 0.48 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 48 Hours | -0.4 mmol/L | Standard Deviation 0.33 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 114 Hours | 0.2 mmol/L | Standard Deviation 0.77 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 54 Hours | -0.4 mmol/L | Standard Deviation 0.43 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 90 Hours | -0.3 mmol/L | Standard Deviation 0.71 |
| No Systemic Anticoagulation | Change From Baseline in Serum Phosphate by Hour | 60 Hours | -0.4 mmol/L | Standard Deviation 0.41 |
Secondary
Change From Baseline in Serum Potassium by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 6 Hours | -0.4 mmol/L | Standard Deviation 0.62 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 12 Hours | -0.4 mmol/L | Standard Deviation 0.66 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 18 Hours | -0.7 mmol/L | Standard Deviation 0.68 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 24 Hours | -0.9 mmol/L | Standard Deviation 0.75 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 30 Hours | -0.9 mmol/L | Standard Deviation 0.7 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 36 Hours | -1.0 mmol/L | Standard Deviation 0.81 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 42 Hours | -1.0 mmol/L | Standard Deviation 0.68 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 48 Hours | -1.0 mmol/L | Standard Deviation 0.62 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 54 Hours | -1.2 mmol/L | Standard Deviation 0.61 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 60 Hours | -1.2 mmol/L | Standard Deviation 0.76 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 66 Hours | -1.2 mmol/L | Standard Deviation 0.81 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 72 Hours | -1.2 mmol/L | Standard Deviation 0.69 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 78 Hours | -1.2 mmol/L | Standard Deviation 0.75 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 84 Hours | -1.3 mmol/L | Standard Deviation 0.77 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 90 Hours | -1.4 mmol/L | Standard Deviation 0.71 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 96 Hours | -1.1 mmol/L | Standard Deviation 0.85 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 102 Hours | -1.2 mmol/L | Standard Deviation 0.72 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 108 Hours | -1.2 mmol/L | Standard Deviation 0.76 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 114 Hours | -1.5 mmol/L | Standard Deviation 0.8 |
| Prismocitrate 18 | Change From Baseline in Serum Potassium by Hour | 120 Hours | -1.1 mmol/L | Standard Deviation 0.63 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 108 Hours | 0.1 mmol/L | Standard Deviation 0.86 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 6 Hours | -0.1 mmol/L | Standard Deviation 0.56 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 66 Hours | 0.3 mmol/L | Standard Deviation 0.58 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 12 Hours | -0.1 mmol/L | Standard Deviation 0.51 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 96 Hours | 0.2 mmol/L | Standard Deviation 0.82 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 18 Hours | -0.1 mmol/L | Standard Deviation 0.43 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 72 Hours | 0.2 mmol/L | Standard Deviation 0.83 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 24 Hours | -0.2 mmol/L | Standard Deviation 0.49 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 120 Hours | 0.1 mmol/L | Standard Deviation 0.75 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 30 Hours | -0.1 mmol/L | Standard Deviation 0.67 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 78 Hours | 0.1 mmol/L | Standard Deviation 0.68 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 36 Hours | -0.0 mmol/L | Standard Deviation 0.69 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 102 Hours | 0 mmol/L | Standard Deviation 0.73 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 42 Hours | -0.0 mmol/L | Standard Deviation 0.58 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 84 Hours | 0.2 mmol/L | Standard Deviation 0.65 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 48 Hours | -0.0 mmol/L | Standard Deviation 0.54 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 114 Hours | 0.2 mmol/L | Standard Deviation 0.85 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 54 Hours | 0.1 mmol/L | Standard Deviation 0.65 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 90 Hours | 0.2 mmol/L | Standard Deviation 0.75 |
| No Systemic Anticoagulation | Change From Baseline in Serum Potassium by Hour | 60 Hours | 0.1 mmol/L | Standard Deviation 0.54 |
Secondary
Change From Baseline in Serum Sodium by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 6 Hours | -1.1 mmol/L | Standard Deviation 2.89 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 12 Hours | -1.6 mmol/L | Standard Deviation 2.06 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 18 Hours | -1.7 mmol/L | Standard Deviation 2.13 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 24 Hours | -1.7 mmol/L | Standard Deviation 4.19 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 30 Hours | -1.9 mmol/L | Standard Deviation 4.03 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 36 Hours | -1.1 mmol/L | Standard Deviation 5.13 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 42 Hours | -0.7 mmol/L | Standard Deviation 5.15 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 48 Hours | -1.5 mmol/L | Standard Deviation 5.74 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 54 Hours | -1.3 mmol/L | Standard Deviation 6.29 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 60 Hours | -1.3 mmol/L | Standard Deviation 5.86 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 66 Hours | -0.7 mmol/L | Standard Deviation 6.1 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 72 Hours | -0.8 mmol/L | Standard Deviation 5.62 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 78 Hours | -1.8 mmol/L | Standard Deviation 5.21 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 84 Hours | -2.2 mmol/L | Standard Deviation 4.95 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 90 Hours | -1.8 mmol/L | Standard Deviation 4.17 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 96 Hours | -2.0 mmol/L | Standard Deviation 4.51 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 102 Hours | -1.8 mmol/L | Standard Deviation 4.9 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 108 Hours | -2.4 mmol/L | Standard Deviation 4.36 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 114 Hours | -2.8 mmol/L | Standard Deviation 4.78 |
| Prismocitrate 18 | Change From Baseline in Serum Sodium by Hour | 120 Hours | -3.7 mmol/L | Standard Deviation 4.39 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 108 Hours | 0.7 mmol/L | Standard Deviation 3.73 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 6 Hours | 0.4 mmol/L | Standard Deviation 1.89 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 66 Hours | 0.3 mmol/L | Standard Deviation 4.11 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 12 Hours | -0.1 mmol/L | Standard Deviation 3.01 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 96 Hours | 2.3 mmol/L | Standard Deviation 3.24 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 18 Hours | 0.5 mmol/L | Standard Deviation 3.39 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 72 Hours | 2.5 mmol/L | Standard Deviation 4.61 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 24 Hours | 0.4 mmol/L | Standard Deviation 4.35 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 120 Hours | 1 mmol/L | Standard Deviation 5.16 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 30 Hours | 0.4 mmol/L | Standard Deviation 4.83 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 78 Hours | 2.6 mmol/L | Standard Deviation 4.06 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 36 Hours | -0.3 mmol/L | Standard Deviation 5.08 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 102 Hours | 1.1 mmol/L | Standard Deviation 3.53 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 42 Hours | -0.4 mmol/L | Standard Deviation 5.04 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 84 Hours | 1.7 mmol/L | Standard Deviation 4.87 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 48 Hours | 1.2 mmol/L | Standard Deviation 4.47 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 114 Hours | 1.4 mmol/L | Standard Deviation 4.12 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 54 Hours | 0.5 mmol/L | Standard Deviation 4.95 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 90 Hours | 2.2 mmol/L | Standard Deviation 4.47 |
| No Systemic Anticoagulation | Change From Baseline in Serum Sodium by Hour | 60 Hours | 1 mmol/L | Standard Deviation 4.99 |
Secondary
Change From Baseline in Temperature at Last Visit
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Temperature at Last Visit | 0.2 degree celsius | Standard Deviation 0.69 |
| No Systemic Anticoagulation | Change From Baseline in Temperature at Last Visit | -0.1 degree celsius | Standard Deviation 1.12 |
Secondary
Change From Baseline in Total Calcium/iCa Ratio by Hour
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 60 Hours | 0.2 ratio | Standard Deviation 0.16 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 30 Hours | 0.2 ratio | Standard Deviation 0.16 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 66 Hours | 0.2 ratio | Standard Deviation 0.19 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 6 Hours | 0.2 ratio | Standard Deviation 0.17 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 72 Hours | 0.2 ratio | Standard Deviation 0.16 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 36 Hours | 0.2 ratio | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 78 Hours | 0.2 ratio | Standard Deviation 0.23 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 84 Hours | 0.2 ratio | Standard Deviation 0.18 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 18 Hours | 0.2 ratio | Standard Deviation 0.13 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 90 Hours | 0.2 ratio | Standard Deviation 0.18 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 42 Hours | 0.3 ratio | Standard Deviation 0.21 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 96 Hours | 0.2 ratio | Standard Deviation 0.2 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 1 Hour | 0.2 ratio | Standard Deviation 0.25 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 102 Hours | 0.2 ratio | Standard Deviation 0.2 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 48 Hours | 0.2 ratio | Standard Deviation 0.2 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 108 Hours | 0.2 ratio | Standard Deviation 0.19 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 24 Hours | 0.3 ratio | Standard Deviation 0.25 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 114 Hours | 0.1 ratio | Standard Deviation 0.17 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 54 Hours | 0.2 ratio | Standard Deviation 0.18 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 120 Hours | 0.2 ratio | Standard Deviation 0.14 |
| Prismocitrate 18 | Change From Baseline in Total Calcium/iCa Ratio by Hour | 12 Hours | 0.2 ratio | Standard Deviation 0.18 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 120 Hours | -0.1 ratio | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 1 Hour | -0.1 ratio | Standard Deviation 0.12 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 6 Hours | -0.1 ratio | Standard Deviation 0.12 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 12 Hours | -0.1 ratio | Standard Deviation 0.12 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 18 Hours | -0.1 ratio | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 24 Hours | -0.1 ratio | Standard Deviation 0.08 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 30 Hours | -0.1 ratio | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 36 Hours | -0.1 ratio | Standard Deviation 0.08 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 42 Hours | -0.1 ratio | Standard Deviation 0.08 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 48 Hours | -0.1 ratio | Standard Deviation 0.07 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 54 Hours | -0.1 ratio | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 60 Hours | -0.1 ratio | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 66 Hours | -0.1 ratio | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 72 Hours | -0.1 ratio | Standard Deviation 0.1 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 84 Hours | -0.1 ratio | Standard Deviation 0.09 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 90 Hours | -0.1 ratio | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 96 Hours | -0.1 ratio | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 102 Hours | -0.1 ratio | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 108 Hours | -0.1 ratio | Standard Deviation 0.14 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 114 Hours | -0.1 ratio | Standard Deviation 0.11 |
| No Systemic Anticoagulation | Change From Baseline in Total Calcium/iCa Ratio by Hour | 78 Hours | -0.1 ratio | Standard Deviation 0.13 |
Secondary
Delivery of Prescribed CRRT Dose by Day
Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour.
Time frame: Up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Delivery of Prescribed CRRT Dose by Day | Day 2 | 33.12 mL/kg/hour | Standard Deviation 9.676 |
| Prismocitrate 18 | Delivery of Prescribed CRRT Dose by Day | Day 4 | 31.93 mL/kg/hour | Standard Deviation 10.187 |
| Prismocitrate 18 | Delivery of Prescribed CRRT Dose by Day | Day 3 | 31.62 mL/kg/hour | Standard Deviation 8.045 |
| Prismocitrate 18 | Delivery of Prescribed CRRT Dose by Day | Day 5 | 32.83 mL/kg/hour | Standard Deviation 11.119 |
| Prismocitrate 18 | Delivery of Prescribed CRRT Dose by Day | Day 1 | 32.3 mL/kg/hour | Standard Deviation 7.064 |
| No Systemic Anticoagulation | Delivery of Prescribed CRRT Dose by Day | Day 5 | 33.31 mL/kg/hour | Standard Deviation 13.103 |
| No Systemic Anticoagulation | Delivery of Prescribed CRRT Dose by Day | Day 1 | 30.34 mL/kg/hour | Standard Deviation 7.407 |
| No Systemic Anticoagulation | Delivery of Prescribed CRRT Dose by Day | Day 2 | 32.49 mL/kg/hour | Standard Deviation 10.191 |
| No Systemic Anticoagulation | Delivery of Prescribed CRRT Dose by Day | Day 3 | 32.29 mL/kg/hour | Standard Deviation 10.533 |
| No Systemic Anticoagulation | Delivery of Prescribed CRRT Dose by Day | Day 4 | 35.19 mL/kg/hour | Standard Deviation 10.95 |
Secondary
Duration of Bleeding Events
Time frame: Up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prismocitrate 18 | Duration of Bleeding Events | 0 Hours | Standard Deviation 0 |
| No Systemic Anticoagulation | Duration of Bleeding Events | 14.4 Hours | Standard Deviation 12.71 |
Secondary
Extracorporeal Circuit Ionized Calcium by Hour
Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter).
Time frame: Up to 120 hours post CRRT treatment initiation
Population: Overall Number of Participants Analyzed (N) reflects FAS, and number of subjects (n) with evaluable data is shown for each individual timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 1 Hour | 0.5 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 6 Hours | 0.5 mmol/L | Standard Deviation 0.13 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 12 Hours | 0.5 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 18 Hours | 0.5 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 24 Hours | 0.5 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 30 Hours | 0.5 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 36 Hours | 0.5 mmol/L | Standard Deviation 0.1 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 42 Hours | 0.5 mmol/L | Standard Deviation 0.23 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 48 Hours | 0.5 mmol/L | Standard Deviation 0.12 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 54 hours | 0.5 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 60 hours | 0.5 mmol/L | Standard Deviation 0.13 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 66 Hours | 0.5 mmol/L | Standard Deviation 0.17 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 72 Hours | 0.4 mmol/L | Standard Deviation 0.1 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 78 Hours | 0.4 mmol/L | Standard Deviation 0.12 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 84 Hours | 0.4 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 90 Hours | 0.4 mmol/L | Standard Deviation 0.1 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 96 Hours | 0.4 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 102 Hours | 0.4 mmol/L | Standard Deviation 0.13 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 108 Hours | 0.4 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 114 Hours | 0.4 mmol/L | Standard Deviation 0.11 |
| Prismocitrate 18 | Extracorporeal Circuit Ionized Calcium by Hour | 120 Hours | 0.5 mmol/L | Standard Deviation 0.16 |
Secondary
Number of Bleeding Events by Location
Time frame: Up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prismocitrate 18 | Number of Bleeding Events by Location | Gastrointestinal | 1 Events |
| Prismocitrate 18 | Number of Bleeding Events by Location | M150 filter | 0 Events |
| Prismocitrate 18 | Number of Bleeding Events by Location | ostomy and rectum | 0 Events |
| Prismocitrate 18 | Number of Bleeding Events by Location | upper Gastrointestinal tract | 0 Events |
| No Systemic Anticoagulation | Number of Bleeding Events by Location | upper Gastrointestinal tract | 1 Events |
| No Systemic Anticoagulation | Number of Bleeding Events by Location | Gastrointestinal | 4 Events |
| No Systemic Anticoagulation | Number of Bleeding Events by Location | ostomy and rectum | 1 Events |
| No Systemic Anticoagulation | Number of Bleeding Events by Location | M150 filter | 1 Events |
Secondary
Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment
Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training. The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period. The training assessment was housed on a restricted access study website. Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment.
Time frame: Prior to study use of Prismocitrate 18
Population: Physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment at each Investigator site. Staff at each site facility passed testing, but the overall number of participants is not known. No analysis of investigator training test scores were conducted as results for individual test questions were not retained for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prismocitrate 18 | Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment | 6 site facility staff |
Secondary
Number of Participants by Number of Blood Transfusions
Time frame: Up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prismocitrate 18 | Number of Participants by Number of Blood Transfusions | 3 Transfusions | 1 participants |
| Prismocitrate 18 | Number of Participants by Number of Blood Transfusions | 27 Transfusions | 0 participants |
| No Systemic Anticoagulation | Number of Participants by Number of Blood Transfusions | 3 Transfusions | 2 participants |
| No Systemic Anticoagulation | Number of Participants by Number of Blood Transfusions | 27 Transfusions | 1 participants |
Secondary
Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious)
Time frame: Up to 30 days post study CRRT treatment completion
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prismocitrate 18 | Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious) | 0 Events |
| No Systemic Anticoagulation | Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious) | 1 Events |
Secondary
Number of Participants With Bleeding Events
Time frame: Up to 120 hours post CRRT treatment initiation
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prismocitrate 18 | Number of Participants With Bleeding Events | 0 Bleeding Events | 16 Participants |
| Prismocitrate 18 | Number of Participants With Bleeding Events | 1 Bleeding Events | 1 Participants |
| Prismocitrate 18 | Number of Participants With Bleeding Events | 2 Bleeding Events | 0 Participants |
| Prismocitrate 18 | Number of Participants With Bleeding Events | 4 Bleeding Events | 0 Participants |
| No Systemic Anticoagulation | Number of Participants With Bleeding Events | 4 Bleeding Events | 1 Participants |
| No Systemic Anticoagulation | Number of Participants With Bleeding Events | 0 Bleeding Events | 13 Participants |
| No Systemic Anticoagulation | Number of Participants With Bleeding Events | 2 Bleeding Events | 0 Participants |
| No Systemic Anticoagulation | Number of Participants With Bleeding Events | 1 Bleeding Events | 3 Participants |