Comparison of RCA and RACD in Extra-renal Purification by SLED
NCT ID: NCT04968587
Last Updated: 2025-06-10
Study Results
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Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2022-02-01
2025-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group 1: RACD - RCA
First period of treatment with Regional Anticoagulation by Citrate-Free Decalcification SLED and second period of treatment with Regional Citrate Anticoagulation SLED
Sustained Low-Efficiency Dialysis
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
Group 2 : RCA - RACD
First period of treatment with Regional Citrate Anticoagulation SLED and second period of treatment with Regional Anticoagulation by Citrate-Free Decalcification SLED
Sustained Low-Efficiency Dialysis
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
Interventions
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Sustained Low-Efficiency Dialysis
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Groupe Hospitalier Sud Ile-de-France
OTHER
Responsible Party
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Locations
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Groupe Hospitalier Sud Ile-de-France
Melun, , France
Countries
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Facility Contacts
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Other Identifiers
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2020-A0122-37
Identifier Type: -
Identifier Source: org_study_id
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