Comparison of RCA and RACD in Extra-renal Purification by SLED (ARDC-SLED)

Comparison of Regional Citrate Anticoagulation (RCA) and Regional Anticoagulation by Citrate-Free Decalcification in Renal (RACD) Replacement Therapy Using Sustained Low-Efficiency Dialysis

One of the main RRT issues is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate Anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol / L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic flow of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aim to compare intermittent RRT using 4% Citrate infusion and without Citrate.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Procedure: Sustained Low-Efficiency Dialysis

Detailed Description

Background: Renal Replacement Therapy (RRT), requires anticoagulation of the extracorporal circuit (ECC) using heparin, citrate or repeated rinsing. Difficulties of implementation or exposition to complications (thrombosis, hemorrhage or electrolyte disorder) are frequent.

Purpose: Regional anticoagulation of the ECC based on ionized calcemia reduction, as using citrate, but induced by the use of a calcium-free dialysate associated with the performance of the hemofilter could reduce these risks and the cost of intermittent RRT. This study aims to compare the efficiency of a regional anticoagulation technique based on the reduction of Ionized Calcium in the extracorporal circuit, without the use of Citrate and with Citrate during intermittent RRT.

Abstract: One of the main RRT issue is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol/L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic passage of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aims at comparing intermittent RRT using 4% Citrate infusion and without Citrate.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arezki AGHER; Phone Number: +33181742228; Email: arezki.agher@ghsif.fr
• Study Contact Backup: Name: TAKOUA FAYALI; Phone Number: +33181742774; Email: drc.promotion@ghsif.com

Study Locations

• France
  • Melun, France, 77000
    • Recruiting
    • Groupe Hospitalier Sud Ile-de-France
    • Contact: Franck Pourcine, MD; Phone Number: +33181742085; Email: franck.pourcine@ghsif.fr
    • Principal Investigator: Franck Pourcine, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patient requiring Renal replacement Therapy

Exclusion Criteria:

• Age < 18 years
• Pregnancy
• Hypercalcemia ≥ 3 mmol/L.
• Major under guardianship
• Major deprived of freedom
• Impossible to obtain free and informed consent
• Presence of hemostasis or coagulation disorders:
• Thrombocytopenia < 30 G/L.
• Curative anticoagulation.
• Severe liver disease with Prothrombin rate <30%.
• Coagulation factor deficit.
• Not registered to a social security system.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1: RACD - RCA; First period of treatment with Regional Anticoagulation by Citrate-Free Decalcification SLED and second period of treatment with Regional Citrate Anticoagulation SLED	Procedure: Sustained Low-Efficiency Dialysis; All patient requiring Renal replacement Therapy in the intensive care unit will be randomized in open order (cross-over) with either Regional anticoagulation with Citrate or Regional anticoagulation by Decalcification without Citrate; Other Names: intermittent haemodialysis equipment with lower blood flow and dialysate flow combined with prolonged sessions
Other: Group 2 : RCA - RACD; First period of treatment with Regional Citrate Anticoagulation SLED and second period of treatment with Regional Anticoagulation by Citrate-Free Decalcification SLED	Procedure: Sustained Low-Efficiency Dialysis; All patient requiring Renal replacement Therapy in the intensive care unit will be randomized in open order (cross-over) with either Regional anticoagulation with Citrate or Regional anticoagulation by Decalcification without Citrate; Other Names: intermittent haemodialysis equipment with lower blood flow and dialysate flow combined with prolonged sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the plasma urea	We will compare plasma urea clearance after reaching the prescribed session time without irreversible coagulation of the extracorporeal circuit, with both methods tested in the study.	up to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the concentration of Ca²+i in post-filter	Measurement at different timepoints after the beginning of the concentration of Ca²+i in post-filter during each RRT session.	30 minutes, 1 hour; 4 hours and 8 hours
Measurement of the concentration of Ca²+i (patient)	Measurement at different timepoints after the beginning of the concentration of Ca²+i (patient) during each RRT session.	30minutes, 1 hour; 4 hours and 8 hours
Measurement of the concentration of Mg2+	Measurement of the concentration of Mg2+ at the end of each RRT session.	8 hours
Measurement of heart rate during each RRT session.	Measurement heart rate during each RRT session.	Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes
Measurement of blood pressure	Measurement of blood pressure during each RRT session.	Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes
Number of circuit losses during each RRT session,	Number of circuit losses during each RRT sessions,	Hour 0; 480 minutes
Number of catheter thrombosis during each RRT session	Number of catheter thrombosis during each RRT session	Hour 0; 480 minutes

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Sud Ile-de-France
• Investigators: Principal Investigator: Franck Pourcine, MD, Groupe Hospitalier Sud Ile-de-France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 2020-A0122-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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