Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06038162

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

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

158

Participants Needed

12

Research Sites

217 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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
  • Patients on VA-ECMO requiring initiation of continuous RRT during treatment
  • Patients with a predicted intensive care stay longer than 24 hours
Not Eligible

You will not qualify if you...

  • Patients without vascular access suitable for new dialysis catheter insertion
  • Patients with high ECMO pressures preventing direct RRT catheter connection
  • Pregnant, parturient, or breastfeeding women
  • Patients deprived of liberty by judicial or administrative decision
  • Patients under psychiatric care
  • Patients under legal protection (guardianship, curatorship)
  • Patients not affiliated with a social security system
  • Patients participating in another interventional renal purification research study

AI-Screening

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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

CONTACT

T

Thomas RIMMELE, Professor MD

CONTACT

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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