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

Not Applicable

Recruiting

• Conditions: Venoarterial Extracorporeal Membrane Oxygenation; Acute Kidney Injury; Renal Replacement Therapy
• Interventions: Procedure: Parallel connection; Procedure: Integrated connection

• Registration Number: NCT06038162
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2024-02-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Patients between 18 and 75 years of age
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VA-ECMO patients with parallel connection	Parallel connection	Patients undergoing VA ECMO with indication for concomitant RRT, assigned to parallel connection group.
VA-ECMO patients with integrated connection	Integrated connection	Patients undergoing VA ECMO with indication for concomitant RRT, assigned to integrated connection group.

Primary Outcome Measures

Name	Time	Method
Hemofilter change rate	Duration of RRT associated with VA-ECMO up to 60 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of days spent in intensive care unit	Duration of RRT associated with VA-ECMO up to 60 days	To assess whether the integrated RRT connection modifies the intensive care unit length of stay
Number of air embolism	Duration of RRT associated with VA-ECMO up to 60 days	To assess whether the integrated RRT connection does not expose the patient to a higher probability of air embolism.; The occurrence of an air embolism is defined as an embolic event with clinical impact of any kind, This occurence is related or not to the use of the dialysis catheter or the connection of the RRT to the VA-ECMO circuit.
Proportion of early hemofilter thromboses	Duration of RRT associated with VA-ECMO up to 60 days	To assess if the integrated RRT connection is associated with a lower proportion of early hemofilter thromboses compared to the parallel connection: number of early hemofilter thromboses normalized by the number of hemofilters used. "Early" is defined as \< 24 hours of use.
Number of bleeding complications	Duration of RRT associated with VA-ECMO up to 60 days	To assess whether the integrated RRT connection reduces bleeding complications associated with the use of an additional vascular access.; The occurrence of a bleeding syndrome is defined as a bleeding requiring transfusion with collection of the number of red blood cells transfused or requiring an invasive procedure (surgery, embolization), and defined or not as related to dialysis catheter placement or RRT connection to VA-ECMO.
Proportion of ECMO circuit thromboses	Duration of RRT associated with VA-ECMO up to 60 days	To assess whether the integrated RRT connection does not expose the ECMO circuit to a higher probability of thrombosis The occurrence of thrombosis on the ECMO circuit is defined as a thrombus on any part of the ECMO circuit requiring a change in the circuit or oxygenator, or on the oxygenator resulting in a deleterious effect on oxygenation, or resulting in significant fibrinolysis
Number of hemolysis	Duration of RRT associated with VA-ECMO up to 60 days	To assess whether the integrated RRT connection does not expose to a higher probability of hemolysis.; The occurrence of intravascular hemolysis is defined as the occurrence of significant hemolytic anemia.
Proportion of hemofilter thromboses	Duration of RRT associated with VA-ECMO up to 60 days	To assess if the integrated RRT connection is associated with a lower proportion of hemofilter thromboses compared to the parallel connection: number of hemofilter thromboses normalized by the number of hemofilters used.
Down-time	Duration of RRT associated with VA-ECMO up to 60 days	To compare the integrated RRT connection to the parallel connection in terms of duration of non-purification periods in relation to the total duration RRT.
Renal function according to KDIGO stage	At hospital discharge up to 60 days after admission	To assess renal function at hospital discharge or at day 60 after admission.
Number of infectious complications	Duration of RRT associated with VA-ECMO up to 60 days	To assess whether the integrated RRT connection reduces the number of infectious complications associated with the use of an additional vascular access.; The infection will be defined as catheter-related in case of documented bacteraemia with positive blood cultures with differential time to positivity or positive catheter culture with the same microorganism.
Death	At 30 days	30-day mortality

Trial Locations

Locations (9)

CHU de Saint Etienne, Hôpital Bellevue, Service de Réanimation polyvalente et soins intensifs post-opératoires; 🇫🇷 Saint-Étienne, France

CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardiologique; 🇫🇷 Bordeaux, France

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

Centre Hospitalo Universitaire de Dijon, Unité Réanimation Cardio-Vasculaire,; 🇫🇷 Dijon, France

CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie réanimation, Hôpital Nord; 🇫🇷 Grenoble, France

Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis Pradel; 🇫🇷 Lyon, France

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

APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital de la Pitié-Salpêtrière; 🇫🇷 Paris, France

APHP, Institut de cardiologie, Service de Médecine Intensive Réanimation, Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France