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NCT Number: NCT04968587

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sustained Low-Efficiency Dialysis

Procedure

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

Primary outcomes

  1. Measurement of the plasma urea

    Time frame: up to 8 hours

    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.

Secondary outcomes

  1. Measurement of the concentration of Ca²+i in post-filter

    Time frame: 30 minutes, 1 hour; 4 hours and 8 hours

    Measurement at different timepoints after the beginning of the concentration of Ca²+i in post-filter during each RRT session.

  2. Measurement of the concentration of Ca²+i (patient)

    Time frame: 30minutes, 1 hour; 4 hours and 8 hours

    Measurement at different timepoints after the beginning of the concentration of Ca²+i (patient) during each RRT session.

  3. Measurement of the concentration of Mg2+

    Time frame: 8 hours

    Measurement of the concentration of Mg2+ at the end of each RRT session.

  4. Measurement of heart rate during each RRT session.

    Time frame: 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 heart rate during each RRT session.

  5. Measurement of blood pressure

    Time frame: 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 during each RRT session.

  6. Number of circuit losses during each RRT session,

    Time frame: Hour 0; 480 minutes

    Number of circuit losses during each RRT sessions,

  7. Number of catheter thrombosis during each RRT session

    Time frame: Hour 0; 480 minutes

    Number of catheter thrombosis during each RRT session

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Sud Ile-de-France

Other

Registry information

Official study title

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

Acronym: ARDC-SLED

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2021
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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