Clinical trial NCT04968587: Comparison of RCA and RACD in Extra-renal Purification by 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Groupe Hospitalier Sud Ile-de-France
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of the plasma urea
timeFrame: up to 8 hours
Secondary outcomes:
measure: Measurement of the concentration of Ca²+i in post-filter
timeFrame: 30 minutes, 1 hour; 4 hours and 8 hours
measure: Measurement of the concentration of Ca²+i (patient)
timeFrame: 30minutes, 1 hour; 4 hours and 8 hours
measure: Measurement of the concentration of Mg2+
timeFrame: 8 hours
measure: Measurement of heart rate during each RRT session.
timeFrame: 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
measure: Measurement of blood pressure
timeFrame: 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
measure: Number of circuit losses during each RRT session,
timeFrame: Hour 0; 480 minutes
measure: Number of catheter thrombosis during each RRT session
timeFrame: Hour 0; 480 minutes
Other outcomes:
Locations:
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile-de-France
Study officials:
References: