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

Acute Kidney Injury Clinical Trial

— ARDC-SLED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968587
• Other study ID #: 2020-A0122-37
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: January 2023
• Source: Groupe Hospitalier Sud Ile-de-France
• Contact: TAKOUA FAYALI
• Phone: +33181742774
• Email: drc.promotion[@]ghsif.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
France	Groupe Hospitalier Sud Ile-de-France	Melun

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Sud Ile-de-France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Measurement of the concentration of Mg2+	Measurement of the concentration of Mg2+ at the end of each RRT session.	8 hours
Secondary	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
Secondary	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
Secondary	Number of circuit losses during each RRT session,	Number of circuit losses during each RRT sessions,	Hour 0; 480 minutes
Secondary	Number of catheter thrombosis during each RRT session	Number of catheter thrombosis during each RRT session	Hour 0; 480 minutes