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

NCT04968587 | Recruiting

• 1 other identifier: 2020-A0122-37
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Measurement of the concentration of Ca²+i in post-filter

  30 minutes, 1 hour; 4 hours and 8 hours

• Measurement of the concentration of Ca²+i (patient)

  30minutes, 1 hour; 4 hours and 8 hours

• Measurement of the concentration of Mg2+

  8 hours

• Measurement of 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

  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

Study Arms (2)

Group 1: RACD - RCA

OTHER

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

Group 2 : RCA - RACD

OTHER

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

Interventions

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

Also known as: intermittent haemodialysis equipment with lower blood flow and dialysate flow combined with prolonged sessions

Group 1: RACD - RCA; Group 2 : RCA - RACD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient requiring Renal replacement Therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier Sud Ile-de-France: lead

Study Sites (1)

Groupe Hospitalier Sud Ile-de-France

Melun, 77000, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Hybrid Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 20, 2021
• Study Start: February 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)