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

Official title

Evaluation of Integrated Versus Parallel Continuous Renal Replacement Therapy Connection in ECMO Patients: a Randomized Controlled Trial

Overview

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.

Interventions

• Procedure Parallel connection
  The RRT machine is connected on a separate vascular access (dialysis catheter).
• Procedure Integrated connection
  A connection of the RRT machine with the input and output lines directly on the ECMO circuit.

Primary outcome measures

• Hemofilter change rate [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]

Secondary outcome measures (11)

• Proportion of early hemofilter thromboses [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Proportion of hemofilter thromboses [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Down-time [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Renal function according to KDIGO stage [Time frame: At hospital discharge up to 60 days after admission]
• Number of infectious complications [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Number of bleeding complications [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Proportion of ECMO circuit thromboses [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Number of hemolysis [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Number of air embolism [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Number of days spent in intensive care unit [Time frame: Duration of RRT associated with VA-ECMO up to 60 days]
• Death [Time frame: At 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 12 centers

• CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardio — Bordeaux
• CHU de Clermont Ferrand, Pôle de médecine péri-opératoire/Chirurgie cardiaque, Hôpital Gab — Clermont-Ferrand
• Centre Hospitalo Universitaire de Dijon, Unité Réanimation Cardio-Vasculaire, — Dijon
• CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie ré — Grenoble
• Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon — Lille
• Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis — Lyon
• CHU de Montpellier, Département d'anesthésie-réanimation, Pôle Cœur-poumons, Hôpital Arnau — Montpellier
• APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital — Paris
• … and 4 more centers

Identifiers

NCT: NCT06038162 · 69HCL22_0894

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗