Comparison of RCA and RACD in Extra-renal Purification by SLED (NCT04968587) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of RCA and RACD in Extra-renal Purification by SLED
France138 participantsStarted 2022-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.