Evaluation of Integrated Versus Parallel Connection for Renal Replacement Therapy in ECMO Patients (EPIC-ECMO)

Civil Hospices of Lyon

Status: Enrolling

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

Treatments: Procedure: Integrated connection; Procedure: Parallel connection

Study type: Interventional

Funder types: Other

Identifiers

NCT06038162

69HCL22_0894

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

VA-ECMO patients with parallel connection

Active Comparator group

Description:

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

Treatment:

Procedure: Parallel connection

VA-ECMO patients with integrated connection

Active Comparator group

Description:

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

Treatment:

Procedure: Integrated connection