NCT06038162 Evaluation of Integrated Versus Parallel Connection for Renal Replacement Therapy in ECMO Patients
| NCT ID | NCT06038162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Venoarterial Extracorporeal Membrane Oxygenation |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2028-02-07 |
Eligibility & Interventions
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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 158 participants in total. It began in 2024-02-07 with a primary completion date of 2028-02-07.
⚠ 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
Extracorporeal membrane oxygenation (ECMO) is an extra-corporeal assistance used in case of respiratory or circulatory failure. In case of circulatory failure, ECMO is in the veno-arterial configuration (VA-ECMO). VA-ECMO patients are at high risk of developing acute kidney injury (AKI) and renal replacement therapy (RRT) may be needed in 50% of ECMO patients. Although the administration of RRT in ECMO patients has major implications, no specific recommendations are currently available. The 2020 Kidney Disease: Improving Global Outcomes (KDIGO) international conference identified the evaluation of RRT in these ECMO patients as a research priority. In 2023, the two main configurations used to administer RRT in ECMO patients are an independent delivery on a separate vascular access (parallel connection) or an integration of the RRT machine directly into the ECMO circuit (integrated connection). The integrated connection may reduce infectious and bleeding complications associated with the use of a second vascular access. However, it can expose the hemofilter and circuit to excessive positive pressures that can trigger pressure alarms in the RRT machine and expose the patient to a theoretical risk of air embolism or hemolysis. Furthermore, there is currently no robust data comparing the hemofilter lifespan with the parallel or with the integrated connection, although the filter lifespan is a crucial parameter to assess the quality of the RRT delivery in the ICU. The investigators recently performed a survey of practices in this context of ECMO patients. The investigators found that both strategies (parallel and integrated connection) are widely used and can be seen as common patient care. The hypothesis tested in this study is the following: when RRT is integrated to the ECMO circuit, the hemofilter lifespan is non inferior to the one when RRT is delivered on a separate vascular access. Only VA-ECMO patients will be enrolled in this trial.
Eligibility 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
Contact & Investigator
Frank BIDAR, MD
STUDY CHAIR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT06038162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venoarterial Extracorporeal Membrane Oxygenation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06038162 currently recruiting?
Yes, NCT06038162 is actively recruiting participants. Contact the research team at frank.bidar@chu-lyon.fr for enrollment information.
Where is the NCT06038162 trial being conducted?
This trial is being conducted at Bordeaux, France, Clermont-Ferrand, France, Dijon, France, Grenoble, France and 8 additional locations.
Who is sponsoring the NCT06038162 clinical trial?
NCT06038162 is sponsored by Hospices Civils de Lyon. The principal investigator is Frank BIDAR, MD at Hospices Civils de Lyon. The trial plans to enroll 158 participants.