Clinical trial NCT06038162: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venoarterial Extracorporeal Membrane Oxygenation
Renal Replacement Therapy
Acute Kidney Injury
Keywords: VA-ECMO
RRT
connection
integrated
parallel
hemofilter
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemofilter change rate
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
Secondary outcomes:
measure: Proportion of early hemofilter thromboses
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Proportion of hemofilter thromboses
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Down-time
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Renal function according to KDIGO stage
timeFrame: At hospital discharge up to 60 days after admission
measure: Number of infectious complications
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Number of bleeding complications
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Proportion of ECMO circuit thromboses
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Number of hemolysis
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Number of air embolism
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Number of days spent in intensive care unit
timeFrame: Duration of RRT associated with VA-ECMO up to 60 days
measure: Death
timeFrame: At 30 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardiologique
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand, Pôle de médecine péri-opératoire/Chirurgie cardiaque, Hôpital Gabriel Montpied
city: Dijon
country: France
facility: Centre Hospitalo Universitaire de Dijon, Unité Réanimation Cardio-Vasculaire,
city: Grenoble
country: France
facility: CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie réanimation, Hôpital Nord
city: Lyon
country: France
facility: Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis Pradel
city: Montpellier
country: France
facility: CHU de Montpellier, Département d'anesthésie-réanimation, Pôle Cœur-poumons, Hôpital Arnaud de Villeneuve
city: Paris
country: France
facility: APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital de la Pitié-Salpêtrière
city: Paris
country: France
facility: APHP, Institut de cardiologie, Service de Médecine Intensive Réanimation, Hôpital Pitié-Salpêtrière
city: Saint-Étienne
country: France
facility: CHU de Saint Etienne, Hôpital Bellevue, Service de Réanimation polyvalente et soins intensifs post-opératoires
Study officials:
affiliation: Hospices Civils de Lyon
name: Frank BIDAR, MD
role: STUDY_CHAIR
References: