New Protocol With Diluted Citrate in Continuous Techniques

Not Applicable

Completed

• Conditions: Citrate Poisoning; Acute Renal Failure; Dialysis; Complications
• Interventions: Other: the same citrate dosification in both types

• Registration Number: NCT04062812
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Concentrated citrate	the same citrate dosification in both types	Initial citrate dose: 3.5 mmol/L Initial calcium dose: 1.9 mmol/L and 1:20 ratio (blood/dialysis) No convection programmed
Diluted citrate	the same citrate dosification in both types	Initial citrate dose 3.5 mmol/L Initial calcium programmed 100% ("compensation dose") only dialysis and ratio 1:10 (blood/dialysis) No fluids in the repositioning scale

Primary Outcome Measures

Name	Time	Method
Dialysis flow	6 hours	Speed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour
Blood flow	6 hours	Speed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min
Calcium dose	6 hours	Amount of calcium that is replenished to the patient when the dialyzed blood is returned. It is measured in%.
Citrate dose	6 hours	Relationship 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

Secondary Outcome Measures

Name	Time	Method
Arterial pH	6 hours	Corresponds to the patient's arterial blood pH figure at the time of observation
Total Ca / Ionic Ca Ratio	24 hours	Relationship between the total calcium and the ionic one of the patient
Magnesium	24 hours	Value of this ion in the patient. It is measured in mmol / l.
Sodium	24 hours	Value of this ion in the patient. It is measured in mmol / l.
Creatinine	24 hours	Creatinine level of the patient at the time of observation
Total calcium	6 hours	Total calcium value. It is measured in mmol / l
Lactate	24 hours	Lactate level of the patient at the time of observation
Potassium	24 hours	Value of this ion in the patient. It is measured in mmol / l.
Urea	24 hours	Urea level of the patient at the time of observation
INR	24 hours	INR level of the patient at the time of observation
Filter operating hours	number of hours	They 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 bicarbonate	6 hours	It is the bicarbonate figure found in arterial blood. It is measured in mmol / l.
Match	24 hours	Value of this ion in the patient. It is measured in mmol / l.
Post-filter ionic calcium	6 hours	Corresponds to the value of ionic calcium by taking the sample at the blood outlet of the dialysis filter. It is measured in mmol / l.
Ionic Calcium Patien	6 hours	It is the ionic calcium value of the patient in a systemic way, preferably arterial. It is measured in mmol / l

Trial Locations

Locations (1)

Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain