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

Last updated: January 16, 2026
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure

Kidney Disease

Renal Failure

Treatment

Parallel connection

Integrated connection

Clinical Study ID

NCT06038162
69HCL22_0894
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients aged above 18 years

  • Patient on VA-ECMO who requires the initiation of continuous RRT during VA-ECMOtreatment

  • Patient with a foreseeable length of stay in intensive care greater than 24 hours

Exclusion

Exclusion Criteria:

  • Patient who does not have a vascular capital allowing for the insertion of a newdialysis catheter to administer RRT and therefore cannot be randomized to theparallel 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 extrapurification renal

Study Design

Total Participants: 158
Treatment Group(s): 2
Primary Treatment: Parallel connection
Phase:
Study Start date:
February 07, 2024
Estimated Completion Date:
April 07, 2028

Connect with a study center

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

    Bordeaux,
    France

    Site Not Available

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

    Bordeaux 3031582,
    France

    Active - Recruiting

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

    Clermont-Ferrand,
    France

    Site Not Available

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

    Clermont-Ferrand 3024635,
    France

    Active - Recruiting

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

    Dijon, 21079
    France

    Site Not Available

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

    Dijon 3021372, 21079
    France

    Active - Recruiting

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

    Grenoble,
    France

    Site Not Available

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

    Grenoble 3014728,
    France

    Active - Recruiting

  • Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon

    Lille 2998324, 59037
    France

    Site Not Available

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

    Lyon,
    France

    Site Not Available

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

    Lyon 2996944,
    France

    Active - Recruiting

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

    Montpellier,
    France

    Site Not Available

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

    Montpellier 2992166,
    France

    Active - Recruiting

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

    Paris,
    France

    Active - Recruiting

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

    Paris,
    France

    Site Not Available

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

    Paris 2988507,
    France

    Active - Recruiting

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

    Paris 2988507,
    France

    Active - Recruiting

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

    Saint-Etienne 2980291,
    France

    Active - Recruiting

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

    Saint-Étienne,
    France

    Site Not Available

  • Centre Hospitalo Universitaire de Toulouse, Hôpital Rangueil - Réanimation polyvalente

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Centre Hospitalo Universitaire de Toulouse, Unité de Chirurgie Cardiaque

    Toulouse 2972315, 31059
    France

    Site Not Available

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