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

Last updated: September 23, 2024
Sponsor: Groupe Hospitalier Sud Ile-de-France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Disease

Kidney Failure

Renal Failure

Treatment

Sustained Low-Efficiency Dialysis

Clinical Study ID

NCT04968587
2020-A0122-37
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patient requiring Renal replacement Therapy

Exclusion

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 Design

Total Participants: 138
Treatment Group(s): 1
Primary Treatment: Sustained Low-Efficiency Dialysis
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • Groupe Hospitalier Sud Ile-de-France

    Melun, 77000
    France

    Active - Recruiting

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