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

NCT ID: NCT06038162

Last Updated: 2026-01-20

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2028-04-07

Brief Summary

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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.

Detailed Description

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Conditions

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Venoarterial Extracorporeal Membrane Oxygenation Renal Replacement Therapy Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Parallel connection

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Integrated connection

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Parallel connection

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

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

Clermont-Ferrand, , France

Site Status RECRUITING

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

Dijon, , France

Site Status RECRUITING

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

Grenoble, , France

Site Status RECRUITING

Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon

Lille, , France

Site Status NOT_YET_RECRUITING

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

Lyon, , France

Site Status RECRUITING

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

Montpellier, , France

Site Status RECRUITING

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

Paris, , France

Site Status RECRUITING

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

Paris, , France

Site Status RECRUITING

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

Saint-Etienne, , France

Site Status RECRUITING

Centre Hospitalo Universitaire de Toulouse, Hôpital Rangueil - Réanimation polyvalente

Toulouse, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalo Universitaire de Toulouse, Unité de Chirurgie Cardiaque

Toulouse, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Frank BIDAR, MD

Role: CONTACT

(33) 472 116 942

Thomas RIMMELE, Professor MD

Role: CONTACT

(33) 472 111 327

Facility Contacts

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Alexandre OUATTARA, Professor MD

Role: primary

(33) 557 656 866

Vedat ELJEZI, Professor MD

Role: primary

(33) 473 751 590

Pierre-Grégoire GUINOT, Professor MD

Role: primary

03.80.29.56.03 ext. +33

Géraldine DESSERTAINE, MD

Role: primary

(33) 476 767 588

Mouhamed Djahoum MOUSSA, MD

Role: primary

03 20 44 59 62 ext. +33

Jean-Luc FELLAHI, Professor MD

Role: primary

(33) 472 118 933

Philippe GAUDARD, MD

Role: primary

(33) 467 335 958

Adrien BOUGLE, MD

Role: primary

(33) 142 162 259

Charles-Edouard LUYT, Professor MD

Role: primary

(33) 142 163 824

Jérôme MOREL, Professor MD

Role: primary

(33) 477 828 329

Fanny VARDON, MD

Role: primary

05 61 32 23 11 ext. +33

François LABASTE, MD

Role: primary

05 61 32 28 22 ext. +33

Other Identifiers

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69HCL22_0894

Identifier Type: -

Identifier Source: org_study_id

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