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New Protocol With Diluted Citrate in Continuous Techniques

Comparison of Diluted vs Concentrated Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: A Quasi-experimental Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04062812
Enrollment
66
Registered
2019-08-20
Start date
2019-08-01
Completion date
2021-12-20
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Citrate Poisoning, Dialysis; Complications

Keywords

sodium citrate, calcaemia, magnesium, phosphorus, ionic calcium

Brief summary

The investigators designed a monitoring and control table of a citrate treatment on a specific monitor. This is the Baxter Prismaflex monitor, with 8.2 software version. Dialysis bath liquids marketed by Baxter: Biphozyl are used. Citrate liquid (1:18) Regiocit is used. The dialysis treatment monitor (CVVHD) is programmed, with a blood / citrate pumps at a rate of 1:10 (1 ml / min of blood: 10 ml / h of dialysis fluid) The starting dose of citrate will be 3.5 mmol / l and the calcium compensation will be 100% Working hypothesis: The patient undergoing citrate anticoagulation according to the designed algorithm will respond with ion stability and pH during the treatment, in addition to achieving an effective cleaning process.

Detailed description

Study design: quasi-experimental design. two groups: 1. Usual protocol with Multifiltrate monitor and citrate (136 mmol/l) 2. Intervention group. New protocol with Prismaflex monitor and citrate (18 mmol/l) Study population Inclusión/exclusion criteria: Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau Hospital with the Intensive Medicine medical team, who require citrate anticoagulation in continuous dialysis therapy and are treated with Baxter Prismaflex monitor. Patients who meet the criteria described above will be followed up in this study. Expected sample size: It is estimated that with 24/12 (group1/2) patients will be enough to achieve our goal Methodology. Information sources: The start of the treatment with Baxter citrate will be given according to the patient's need and subject to a basic medical decision. From here the research team will enter. The investigation team will never influence the medical decision. Since such a treatment is started, the main investigator will assign a number to the dialysis circuit and will be followed, every six hours, for the most important variables. The rest of the variables will be collected at least once a day and according to the patient's situation.

Interventions

OTHERthe same citrate dosification in both types

match concentrated and dilute citrate protocol

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

Quasi-experimental design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau with the medical team of Intensive Medicine, who require anticoagulation with citrate in continuous dialysis therapy and are treated with the Baxter monitor.

Exclusion criteria

* parenteral nutrition * pregnancy * cardiac surgery * coronary patients

Design outcomes

Primary

MeasureTime frameDescription
Dialysis flow6 hoursSpeed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour
Blood flow6 hoursSpeed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min
Citrate dose6 hoursRelationship that exists between the liquid we infuse (which contains 18mmol / L citrate) and the blood pump. It is measured in mmol citrate / liter of blood
Calcium dose6 hoursAmount of calcium that is replenished to the patient when the dialyzed blood is returned. It is measured in%.

Secondary

MeasureTime frameDescription
Potassium24 hoursValue of this ion in the patient. It is measured in mmol / l.
Urea24 hoursUrea level of the patient at the time of observation
Filter operating hoursnumber of hoursThey correspond to the hours that go from the beginning of the circuit until the end of the circuit in which the fungible is discarded. It can be several days
Arterial pH6 hoursCorresponds to the patient's arterial blood pH figure at the time of observation
Arterial bicarbonate6 hoursIt is the bicarbonate figure found in arterial blood. It is measured in mmol / l.
Creatinine24 hoursCreatinine level of the patient at the time of observation
Ionic Calcium Patien6 hoursIt is the ionic calcium value of the patient in a systemic way, preferably arterial. It is measured in mmol / l
Total calcium6 hoursTotal calcium value. It is measured in mmol / l
Total Ca / Ionic Ca Ratio24 hoursRelationship between the total calcium and the ionic one of the patient
Match24 hoursValue of this ion in the patient. It is measured in mmol / l.
Magnesium24 hoursValue of this ion in the patient. It is measured in mmol / l.
Post-filter ionic calcium6 hoursCorresponds to the value of ionic calcium by taking the sample at the blood outlet of the dialysis filter. It is measured in mmol / l.
INR24 hoursINR level of the patient at the time of observation
Lactate24 hoursLactate level of the patient at the time of observation
Sodium24 hoursValue of this ion in the patient. It is measured in mmol / l.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026