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

RecruitingNAAges 18 Years - anyAllGroupe Hospitalier Sud Ile-de-France
NCT04968587 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Sustained Low-Efficiency Dialysis
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Where

1 site
Groupe Hospitalier Sud Ile-de-France
Melun, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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