New Protocol With Diluted Citrate in Continuous Techniques

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062812
• Other study ID #: IIBSP-CIT-2019-34
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 20, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Dialysis; Complications
• Poisoning

Intervention

Other:
• the same citrate dosification in both types
match concentrated and dilute citrate protocol

Locations

Country	Name	City	State
Spain	Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dialysis flow	Speed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour	6 hours
Primary	Blood flow	Speed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min	6 hours
Primary	Citrate dose	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	6 hours
Primary	Calcium dose	Amount of calcium that is replenished to the patient when the dialyzed blood is returned. It is measured in%.	6 hours
Secondary	Filter operating 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	number of hours
Secondary	Arterial pH	Corresponds to the patient's arterial blood pH figure at the time of observation	6 hours
Secondary	Arterial bicarbonate	It is the bicarbonate figure found in arterial blood. It is measured in mmol / l.	6 hours
Secondary	Post-filter ionic calcium	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.	6 hours
Secondary	Ionic Calcium Patien	It is the ionic calcium value of the patient in a systemic way, preferably arterial. It is measured in mmol / l	6 hours
Secondary	Total calcium	Total calcium value. It is measured in mmol / l	6 hours
Secondary	Total Ca / Ionic Ca Ratio	Relationship between the total calcium and the ionic one of the patient	24 hours
Secondary	Match	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Secondary	Magnesium	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Secondary	Sodium	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Secondary	Potassium	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Secondary	Urea	Urea level of the patient at the time of observation	24 hours
Secondary	Creatinine	Creatinine level of the patient at the time of observation	24 hours
Secondary	INR	INR level of the patient at the time of observation	24 hours
Secondary	Lactate	Lactate level of the patient at the time of observation	24 hours