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NCT Number: NCT06038162

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

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.

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Key information

Conditions

Venoarterial Extracorporeal Membrane Oxygenation Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Renal Replacement Therapy Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parallel connection

Procedure

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

Integrated connection

Procedure

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

Primary outcomes

  1. Hemofilter change rate

    Time frame: 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 outcomes

  1. Proportion of early hemofilter thromboses

    Time frame: 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.

  2. Proportion of hemofilter thromboses

    Time frame: 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.

  3. Down-time

    Time frame: 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.

  4. Renal function according to KDIGO stage

    Time frame: At hospital discharge up to 60 days after admission

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

  5. Number of infectious complications

    Time frame: 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.

  6. Number of bleeding complications

    Time frame: 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.

  7. Proportion of ECMO circuit thromboses

    Time frame: 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

  8. Number of hemolysis

    Time frame: 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.

  9. Number of air embolism

    Time frame: 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.

  10. Number of days spent in intensive care unit

    Time frame: 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

  11. Death

    Time frame: At 30 days

    30-day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Frank BIDAR, MD

CONTACT

[email protected]

(33) 472 116 942

Thomas RIMMELE, Professor MD

CONTACT

[email protected]

(33) 472 111 327

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: EPIC-ECMO

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 14, 2023
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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