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

NCT06038162 | Recruiting

• 1 other identifier: 69HCL22_0894
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 12

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.

Conditions

Venoarterial Extracorporeal Membrane Oxygenation; Renal Replacement Therapy; Acute Kidney Injury

Keywords

VA-ECMO; RRT; connection; integrated; parallel; hemofilter

Outcome Measures

Primary Outcomes (1)

• Hemofilter change rate

  To assess whether integrated RRT connection in VA-ECMO patients results in a non-inferior hemofilter change rate compared to the parallel connection. The hemofilter change rate is defined as the number of hemofilter replacements observed during the period between the start and the end of the RRT session, normalized by the duration of the session.

  Duration of RRT associated with VA-ECMO up to 60 days

Secondary Outcomes (11)

• Proportion of early hemofilter thromboses

  Duration of RRT associated with VA-ECMO up to 60 days

• Proportion of hemofilter thromboses

  Duration of RRT associated with VA-ECMO up to 60 days

• Down-time

  Duration of RRT associated with VA-ECMO up to 60 days

• Renal function according to KDIGO stage

  At hospital discharge up to 60 days after admission

• Number of infectious complications

  Duration of RRT associated with VA-ECMO up to 60 days

Study Arms (2)

VA-ECMO patients with parallel connection

ACTIVE COMPARATOR

Patients undergoing VA ECMO with indication for concomitant RRT, assigned to parallel connection group.

Procedure: Parallel connection

VA-ECMO patients with integrated connection

ACTIVE COMPARATOR

Patients undergoing VA ECMO with indication for concomitant RRT, assigned to integrated connection group.

Procedure: Integrated connection

Interventions

Parallel connection PROCEDURE

The RRT machine is connected on a separate vascular access (dialysis catheter).

VA-ECMO patients with parallel connection

Integrated connection PROCEDURE

A connection of the RRT machine with the input and output lines directly on the ECMO circuit.

VA-ECMO patients with integrated connection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (12)

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

Bordeaux, France

RECRUITING

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

Clermont-Ferrand, France

RECRUITING

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

Dijon, 21079, France

RECRUITING

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

Grenoble, France

RECRUITING

Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon

Lille, 59037, France

NOT YET RECRUITING

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

Lyon, France

RECRUITING

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

Montpellier, France

RECRUITING

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

Paris, France

RECRUITING

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

Paris, France

RECRUITING

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

Saint-Etienne, France

RECRUITING

Centre Hospitalo Universitaire de Toulouse, Hôpital Rangueil - Réanimation polyvalente

Toulouse, 31059, France

NOT YET RECRUITING

Centre Hospitalo Universitaire de Toulouse, Unité de Chirurgie Cardiaque

Toulouse, 31059, France

NOT YET RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Frank BIDAR, MD

  Hospices Civils de Lyon

  STUDY CHAIR

Central Study Contacts

Frank BIDAR, MD

CONTACT

(33) 472 116 942; frank.bidar@chu-lyon.fr

Thomas RIMMELE, Professor MD

CONTACT

(33) 472 111 327; thomas.rimmele@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 14, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): February 7, 2028
• Study Completion (Estimated): April 7, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

FR (12)