Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reductio… (NCT06369064) | Clinical Trial Compass
RecruitingNot Applicable
Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient
France80 participantsStarted 2024-07-03
Plain-language summary
In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).
To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).
In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.
The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT.
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:
* Adult patients hospitalized in ICU
* Undergo RRT session because of AKI stage 3
* At least one among criteria: pH \< 7,20 / Blood urea \> 30mM / Fluid overload uncontrolled by with PaCO₂ \< 35 mmHg or mixed acidosis with PaCO₂ \< 50 mmHg.
* Oliguria lasting 72 hours or longer
* Patients undergoing their first session of extracorporeal blood purification, initiated less than 12 hours prior to randomization
* Patient having given free and informed consent, and having signed the consent form or patient included in an emergency situation
* Patient affiliated with Social Security.
Exclusion criteria:
* End-stage chronic kidney disease on dialysis
* Intoxication with a dialyzable toxin (lithium
* Criteria for emergency dialysis initiation: hyperkaliemia \>6,5mM with electrocardiographic signs
* Medical contraindication to regional citrate: severe liver failure
* Medical contraindication to anticoagulation or heparin anticoagulation: heparin induced thrombopenia or uncontrolled bleeding
* Pregnant women, parturient or breast-feeding patient
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.