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

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.

Study Overview

• Status: Completed
• Conditions: Acute Renal Failure; Dialysis; Complications; Citrate Poisoning
• Intervention / Treatment: Other: the same citrate dosification in both types

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Adult patients admitted to our service with acute renal failure

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diluted citrate; 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	Other: the same citrate dosification in both types; match concentrated and dilute citrate protocol
Active Comparator: Concentrated citrate; Initial citrate dose: 3.5 mmol/L Initial calcium dose: 1.9 mmol/L and 1:20 ratio (blood/dialysis) No convection programmed	Other: the same citrate dosification in both types; match concentrated and dilute citrate protocol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Arterial pH	Corresponds to the patient's arterial blood pH figure at the time of observation	6 hours
Arterial bicarbonate	It is the bicarbonate figure found in arterial blood. It is measured in mmol / l.	6 hours
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
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
Total calcium	Total calcium value. It is measured in mmol / l	6 hours
Total Ca / Ionic Ca Ratio	Relationship between the total calcium and the ionic one of the patient	24 hours
Match	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Magnesium	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Sodium	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Potassium	Value of this ion in the patient. It is measured in mmol / l.	24 hours
Urea	Urea level of the patient at the time of observation	24 hours
Creatinine	Creatinine level of the patient at the time of observation	24 hours
INR	INR level of the patient at the time of observation	24 hours
Lactate	Lactate level of the patient at the time of observation	24 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: phosphorus; magnesium; sodium citrate; calcaemia; ionic calcium
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Poisoning; Acute Kidney Injury
• Other Study ID Numbers: IIBSP-CIT-2019-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No