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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parallel connection

    Procedure/Surgery

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

  • Integrated connection

    Procedure/Surgery

    A connection of the RRT machine with the input and output lines directly on the ECMO circuit.

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: VA-ECMO patients with parallel connectionActive comparator 1 intervention
Group B: VA-ECMO patients with integrated connectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemofilter change rate

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.

Time frame
Duration of RRT associated with VA-ECMO up to 60 days

Secondary outcomes

1

Proportion of early hemofilter thromboses

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.

Time frame
Duration of RRT associated with VA-ECMO up to 60 days
2

Proportion of hemofilter thromboses

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.

Time frame
Duration of RRT associated with VA-ECMO up to 60 days
3

Down-time

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.

Time frame
Duration of RRT associated with VA-ECMO up to 60 days
4

Renal function according to KDIGO stage

To assess renal function at hospital discharge or at day 60 after admission.

Time frame
At hospital discharge up to 60 days after admission

Other outcomes

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