NCT04968587 Comparison of RCA and RACD in Extra-renal Purification by SLED
| NCT ID | NCT04968587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe Hospitalier Sud Ile-de-France |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2022-02-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT04968587 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04968587 currently recruiting?
Yes, NCT04968587 is actively recruiting participants. Visit ClinicalTrials.gov or contact Groupe Hospitalier Sud Ile-de-France to inquire about joining.
Where is the NCT04968587 trial being conducted?
This trial is being conducted at Melun, France.
Who is sponsoring the NCT04968587 clinical trial?
NCT04968587 is sponsored by Groupe Hospitalier Sud Ile-de-France. The trial plans to enroll 138 participants.
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