NCT06038162

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-07
• Primary completion: 2028-02-07
• Completion: 2028-04-07
• First posted: 2023-09-14
• Last updated: 2026-01-20

Locations

12 sites across 1 country: France