Comparing two methods of renal replacement therapy for patients on ECMO
Evaluation of Integrated Versus Parallel Continuous Renal Replacement Therapy Connection in ECMO Patients: a Randomized Controlled Trial
This study is testing two different ways to provide kidney treatment for patients on ECMO to see which method causes fewer complications like infections and bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 12 sites (Bordeaux and 11 other locations) |
| Trial ID | NCT06038162 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different methods for administering renal replacement therapy (RRT) in patients undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The two methods being compared are an integrated connection, where the RRT machine is directly incorporated into the ECMO circuit, and a parallel connection, which uses a separate vascular access. The goal is to determine which method may reduce complications such as infections and bleeding, which are critical concerns for patients on ECMO. The study aims to provide evidence-based recommendations for RRT in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are on VA-ECMO and require continuous renal replacement therapy.
Not a fit: Patients who do not have suitable vascular access for RRT or those with high pressures on ECMO that prevent the use of a direct RRT catheter will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients requiring renal replacement therapy while on ECMO.
How similar studies have performed: While there is limited research specifically comparing these two methods in ECMO patients, the evaluation of RRT in this context has been identified as a priority, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged above 18 years * Patient on VA-ECMO who requires the initiation of continuous RRT during VA-ECMO treatment * Patient with a foreseeable length of stay in intensive care greater than 24 hours Exclusion Criteria: * Patient who does not have a vascular capital allowing for the insertion of a new dialysis catheter to administer RRT and therefore cannot be randomized to the parallel connection group * High pressures monitored on ECMO not allowing direct RRT catherter on ECMO * Pregnant, parturient, or breastfeeding women * Patient deprived of liberty by a judicial or administrative decision * Patient under psychiatric care * Patient subject to a legal protection measure (guardianship, curators) * Patient not affiliated to a social security system * Patient participating in another interventional research study in the field of extra purification renal
Where this trial is running
Bordeaux and 11 other locations
- CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardiologique — Bordeaux, France (Recruiting)
- CHU de Clermont Ferrand, Pôle de médecine péri-opératoire/Chirurgie cardiaque, Hôpital Gabriel Montpied — Clermont-Ferrand, France (Recruiting)
- Centre Hospitalo Universitaire de Dijon, Unité Réanimation Cardio-Vasculaire, — Dijon, France (Recruiting)
- CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie réanimation, Hôpital Nord — Grenoble, France (Recruiting)
- Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon — Lille, France (Not_yet_recruiting)
- Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis Pradel — Lyon, France (Recruiting)
- CHU de Montpellier, Département d'anesthésie-réanimation, Pôle Cœur-poumons, Hôpital Arnaud de Villeneuve — Montpellier, France (Recruiting)
- APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital de la Pitié-Salpêtrière — Paris, France (Recruiting)
- APHP, Institut de cardiologie, Service de Médecine Intensive Réanimation, Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
- CHU de Saint Etienne, Hôpital Bellevue, Service de Réanimation polyvalente et soins intensifs post-opératoires — Saint-Etienne, France (Recruiting)
- Centre Hospitalo Universitaire de Toulouse, Hôpital Rangueil - Réanimation polyvalente — Toulouse, France (Not_yet_recruiting)
- Centre Hospitalo Universitaire de Toulouse, Unité de Chirurgie Cardiaque — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Frank BIDAR, MD
- Email: frank.bidar@chu-lyon.fr
- Phone: (33) 472 116 942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.