Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06038162

Evaluation of Integrated Versus Parallel Continuous Renal Replacement Therapy Connection in ECMO Patients A Randomized Controlled Trial

Led by Hospices Civils de Lyon · Updated on 2026-01-20

158

Participants Needed

12

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on patients undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO), a life-support technique used when the heart or lungs fail. These patients often develop acute kidney injury (AKI) and may need renal replacement therapy (RRT). The study evaluates two main ways of delivering RRT during VA-ECMO: using a separate vascular access (parallel connection) or integrating the RRT machine directly into the ECMO circuit (integrated connection). The goal is to compare these methods, as current guidelines lack specific recommendations and the quality of RRT delivery is crucial for patient care. Participants will be randomly assigned to one of two groups. One group will receive RRT through a separate catheter (parallel connection), while the other group's RRT machine will be connected directly to the ECMO circuit (integrated connection). The study will monitor the duration and quality of RRT delivery over a period of up to 60 days during VA-ECMO treatment. The investigation includes measuring complications like infections, bleeding, and hemofilter lifespan associated with each method. During the study, participants will be closely monitored in intensive care units. Researchers will track hemofilter changes, thrombosis events, downtime of RRT, kidney function at hospital discharge, and other complications such as hemolysis and air embolism. The study will also record the number of days participants spend in intensive care and mortality at 30 days. This detailed monitoring will help assess the safety and performance of both RRT connection methods throughout the treatment period.

CONDITIONS

Brief Title

Evaluation of Integrated Versus Parallel Connection for Renal Replacement Therapy in ECMO Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - Up to 60 days

Participants receive continuous renal replacement therapy (RRT) connected either in parallel or integrated with the ECMO circuit during their VA-ECMO treatment.

Participants have continuous treatment during VA-ECMO stay with regular monitoring

Follow-up

Duration - Up to 60 days after treatment initiation

Participants are monitored for renal function, complications, and survival outcomes up to 60 days after treatment initiation and at hospital discharge.

Follow-up assessments at hospital discharge and up to 30 days post treatment

Trial Site Locations

Total: 12 locations

1

CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardiologique

Bordeaux, France

Actively Recruiting

2

CHU de Clermont Ferrand, Pôle de médecine péri-opératoire/Chirurgie cardiaque, Hôpital Gabriel Montpied

Clermont-Ferrand, France

Actively Recruiting

3

Centre Hospitalo Universitaire de Dijon, Unité Réanimation Cardio-Vasculaire,

Dijon, France, 21079

Actively Recruiting

4

CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie réanimation, Hôpital Nord

Grenoble, France

Actively Recruiting

5

Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon

Lille, France, 59037

Not Yet Recruiting

6

Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis Pradel

Lyon, France

Actively Recruiting

7

CHU de Montpellier, Département d'anesthésie-réanimation, Pôle Cœur-poumons, Hôpital Arnaud de Villeneuve

Montpellier, France

Actively Recruiting

8

APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital de la Pitié-Salpêtrière

Paris, France

Actively Recruiting

9

APHP, Institut de cardiologie, Service de Médecine Intensive Réanimation, Hôpital Pitié-Salpêtrière

Paris, France

Actively Recruiting

10

CHU de Saint Etienne, Hôpital Bellevue, Service de Réanimation polyvalente et soins intensifs post-opératoires

Saint-Etienne, France

Actively Recruiting

11

Centre Hospitalo Universitaire de Toulouse, Hôpital Rangueil - Réanimation polyvalente

Toulouse, France, 31059

Not Yet Recruiting

12

Centre Hospitalo Universitaire de Toulouse, Unité de Chirurgie Cardiaque

Toulouse, France, 31059

Not Yet Recruiting

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Research Team

F

Frank BIDAR, MD

T

Thomas RIMMELE, Professor MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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