Evaluation of Integrated Versus Parallel Connection for Renal Replacement Therapy in ECMO Patients
NCT ID: NCT06038162
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
158 participants
INTERVENTIONAL
2024-02-07
2028-04-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VA-ECMO patients with parallel connection
Patients undergoing VA ECMO with indication for concomitant RRT, assigned to parallel connection group.
Parallel connection
The RRT machine is connected on a separate vascular access (dialysis catheter).
VA-ECMO patients with integrated connection
Patients undergoing VA ECMO with indication for concomitant RRT, assigned to integrated connection group.
Integrated connection
A connection of the RRT machine with the input and output lines directly on the ECMO circuit.
Interventions
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Integrated connection
A connection of the RRT machine with the input and output lines directly on the ECMO circuit.
Parallel connection
The RRT machine is connected on a separate vascular access (dialysis catheter).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Frank BIDAR, MD
Role: STUDY_CHAIR
Hospices Civils de Lyon
Locations
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CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardiologique
Bordeaux, , France
CHU de Clermont Ferrand, Pôle de médecine péri-opératoire/Chirurgie cardiaque, Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Centre Hospitalo Universitaire de Dijon, Unité Réanimation Cardio-Vasculaire,
Dijon, , France
CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie réanimation, Hôpital Nord
Grenoble, , France
Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon
Lille, , France
Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis Pradel
Lyon, , France
CHU de Montpellier, Département d'anesthésie-réanimation, Pôle Cœur-poumons, Hôpital Arnaud de Villeneuve
Montpellier, , France
APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital de la Pitié-Salpêtrière
Paris, , France
APHP, Institut de cardiologie, Service de Médecine Intensive Réanimation, Hôpital Pitié-Salpêtrière
Paris, , France
CHU de Saint Etienne, Hôpital Bellevue, Service de Réanimation polyvalente et soins intensifs post-opératoires
Saint-Etienne, , France
Centre Hospitalo Universitaire de Toulouse, Hôpital Rangueil - Réanimation polyvalente
Toulouse, , France
Centre Hospitalo Universitaire de Toulouse, Unité de Chirurgie Cardiaque
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL22_0894
Identifier Type: -
Identifier Source: org_study_id
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