Acute Kidney Injury, End-stage Renal Disease
Conditions
Brief summary
Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.
Interventions
DEVICEcontinuous renal replacement therapy using System One (TM) setup (Nxstage)
Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates
Sponsors
St. Louis University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-89 * Acute renal failure or end-stage renal disease necessitating CRRT * Admitted to the MICU service * If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor * If on vasopressor/inotropic agent, at stable pressor dose for at least four hours * If on IV fluids, stable dose of crystalloids \<= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of CRRT * Mean arterial pressure (MAP) \>= 65 * Arterial catheter present for continuous blood pressure monitoring * CRRT duration of 48 hours or less using NxStage System One dialysis system * successfully tolerated CRRT for at least 4 hours without clotting or hemodynamic instability * no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period
Exclusion criteria
* listed for organ transplant * atrial fibrillation, other irregular heart rhythm, unstable arrhythmia * need for more than one intravenous vasopressor agent * intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine) * therapeutic anticoagulation being administered * known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization * known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days. * dialysis catheter malfunction and unable to maintain target blood flow rate * fluid removal (ultrafiltration) rate \> 100mL/hour
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Change | 10 minutes | Change in mean arterial pressure from period 1 to period 2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Arm The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics
continuous renal replacement therapy using System One (TM) setup (Nxstage): Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Experimental Arm | — |
|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 7 | — |
| mean arterial pressure | 79 mmHg STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 6 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Blood Pressure Change
Change in mean arterial pressure from period 1 to period 2
Time frame: 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Arm | Blood Pressure Change | -0.2 mmHg | Standard Deviation 2 |