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

Groupe Hospitalier Sud Ile-de-France

Status: Enrolling

Conditions: Acute Kidney Injury

Treatments: Procedure: Sustained Low-Efficiency Dialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04968587

2020-A0122-37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

138 participants in 2 patient groups

Group 1: RACD - RCA

Other group

Description:

First period of treatment with Regional Anticoagulation by Citrate-Free Decalcification SLED and second period of treatment with Regional Citrate Anticoagulation SLED

Treatment:

Procedure: Sustained Low-Efficiency Dialysis

Group 2 : RCA - RACD

Other group

Description:

First period of treatment with Regional Citrate Anticoagulation SLED and second period of treatment with Regional Anticoagulation by Citrate-Free Decalcification SLED

Treatment:

Procedure: Sustained Low-Efficiency Dialysis