Venoarterial Extracorporeal Membrane OxygenationEPIC-ECMONCT06038162
Evaluation of Integrated Versus Parallel Connection for Renal Replacement Therapy in ECMO Patients
A study testing Parallel connection and Integrated connection in people with Venoarterial Extracorporeal Membrane Oxygenation and Renal Replacement Therapy, run by Hospices Civils de Lyon at 12 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venoarterial Extracorporeal Membrane Oxygenation, Renal Replacement Therapy, Acute Kidney Injury
- What is being tested?
- Parallel connection and Integrated connection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 12 sitesFrance
- Study dates
- 7 Feb 2024to 7 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardiologique
Bordeaux
Alexandre OUATTARA, Professor MD, (33) 557 656 866, alexandre.ouattara@chu-bordeaux.fr
- Recruiting
CHU de Clermont Ferrand, Pôle de médecine péri-opératoire/Chirurgie cardiaque, Hôpital Gabriel Montpied
Clermont-Ferrand
Vedat ELJEZI, Professor MD, (33) 473 751 590, veljezi@chu-clermontferrand.fr
- Recruiting
Centre Hospitalo Universitaire de Dijon, Unité Réanimation Cardio-Vasculaire,
Dijon, 21079
Pierre-Grégoire GUINOT, Professor MD, 03.80.29.56.03 ext. +33, pierregregoire.guinot@chu-dijon.fr
- Recruiting
CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie réanimation, Hôpital Nord
Grenoble
Géraldine DESSERTAINE, MD, (33) 476 767 588, Gdessertaine@chu-grenoble.fr
- Not yet recruiting
Centre Hospitalo Universitaire de Lille, Institut Coeur Poumon
Lille, 59037
Mouhamed Djahoum MOUSSA, MD, 03 20 44 59 62 ext. +33, mouhamed.MOUSSA@chu-lille.fr
- Recruiting
Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis Pradel
Lyon
Jean-Luc FELLAHI, Professor MD, (33) 472 118 933, Jean-luc.fellahi@chu-lyon.fr
- Recruiting
CHU de Montpellier, Département d'anesthésie-réanimation, Pôle Cœur-poumons, Hôpital Arnaud de Villeneuve
Montpellier
Philippe GAUDARD, MD, (33) 467 335 958, p-gaudard@chu-montpellier.fr
- Recruiting
APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital de la Pitié-Salpêtrière
Paris
Adrien BOUGLE, MD, (33) 142 162 259, Adrien.bougle@aphp.fr
- Recruiting
APHP, Institut de cardiologie, Service de Médecine Intensive Réanimation, Hôpital Pitié-Salpêtrière
Paris
Charles-Edouard LUYT, Professor MD, (33) 142 163 824, Charles-edouard.luyt@aphp.fr
- Recruiting
CHU de Saint Etienne, Hôpital Bellevue, Service de Réanimation polyvalente et soins intensifs post-opératoires
Saint-Etienne
Jérôme MOREL, Professor MD, (33) 477 828 329, Jerome.morel@chu-st-etienne.fr
- Not yet recruiting
Centre Hospitalo Universitaire de Toulouse, Hôpital Rangueil - Réanimation polyvalente
Toulouse, 31059
Fanny VARDON, MD, 05 61 32 23 11 ext. +33, vardon.f@chu-toulouse.fr
- Not yet recruiting
Centre Hospitalo Universitaire de Toulouse, Unité de Chirurgie Cardiaque
Toulouse, 31059
François LABASTE, MD, 05 61 32 28 22 ext. +33, labaste.f@chu-toulouse.fr
About this study
Official title: Evaluation of Integrated Versus Parallel Continuous Renal Replacement Therapy Connection in ECMO Patients: a Randomized Controlled 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.
- Conditions
- Venoarterial Extracorporeal Membrane Oxygenation, Renal Replacement Therapy, Acute Kidney Injury
- Being tested
- Parallel connection, Integrated connection
- Keywords
- VA-ECMO, RRT, connection, integrated, parallel, hemofilter
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parallel connectionProcedure or surgery
The RRT machine is connected on a separate vascular access (dialysis catheter).
Integrated connectionProcedure or surgery
A connection of the RRT machine with the input and output lines directly on the ECMO circuit.
| Study group | Role | What they receive |
|---|---|---|
| VA-ECMO patients with parallel connection | Active comparator | Patients undergoing VA ECMO with indication for concomitant RRT, assigned to parallel connection group. Receives: Procedure: Parallel connection |
| VA-ECMO patients with integrated connection | Active comparator | Patients undergoing VA ECMO with indication for concomitant RRT, assigned to integrated connection group. Receives: Procedure: Integrated connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Secondary outcomes (11)
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Renal function according to KDIGO stage
To assess renal function at hospital discharge or at day 60 after admission.
Measured: At hospital discharge up to 60 days after admission
Number of infectious complications
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Number of bleeding complications
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Proportion of ECMO circuit thromboses
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
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Number of hemolysis
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Number of air embolism
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.
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Number of days spent in intensive care unit
To assess whether the integrated RRT connection modifies the intensive care unit length of stay
Measured: Duration of RRT associated with VA-ECMO up to 60 days
Death
30-day mortality
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start7 Feb 2024
- Primary completion7 Feb 2028 (estimated)
- Study completion7 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venoarterial Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank BIDAR, MD, Study chair, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038162
- Sponsor's protocol ID
- 69HCL22_0894
- Acronym
- EPIC-ECMO
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Integrated Versus Parallel Continuous Renal Replacement Therapy Connection in ECMO Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06038162
- Acronym / sponsor ID
- EPIC-ECMO / 69HCL22_0894
- Conditions
- Venoarterial Extracorporeal Membrane Oxygenation, Renal Replacement Therapy, Acute Kidney Injury
- Keywords
- VA-ECMO, RRT, connection, integrated, parallel, hemofilter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 7 Feb 2028 (estimated)
- Study completion
- 7 Apr 2028 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA-ECMO patients with parallel connection | Active comparator | Procedure: Parallel connectionPatients undergoing VA ECMO with indication for concomitant RRT, assigned to parallel connection group. |
| VA-ECMO patients with integrated connection | Active comparator | Procedure: Integrated connectionPatients undergoing VA ECMO with indication for concomitant RRT, assigned to integrated connection group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parallel connectionThe RRT machine is connected on a separate vascular access (dialysis catheter). | Procedure or surgery | VA-ECMO patients with parallel connection |
| Integrated connectionA connection of the RRT machine with the input and output lines directly on the ECMO circuit. | Procedure or surgery | VA-ECMO patients with integrated connection |
Primary outcome
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.
11 secondary outcomes
Proportion of early hemofilter thromboses
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Proportion of hemofilter thromboses
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Down-time
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Renal function according to KDIGO stage
Time frame: At hospital discharge up to 60 days after admission
Number of infectious complications
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Number of bleeding complications
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Proportion of ECMO circuit thromboses
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Number of hemolysis
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Number of air embolism
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Number of days spent in intensive care unit
Time frame: Duration of RRT associated with VA-ECMO up to 60 days
Death
Time frame: At 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank BIDAR, MD study chair
Hospices Civils de Lyon
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parallel connection and Integrated connection in people with Venoarterial Extracorporeal Membrane Oxygenation and Renal Replacement Therapy, run by Hospices Civils de Lyon at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank BIDAR, MD ((33) 472 116 942, frank.bidar@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemofilter change rate (time frame: Duration of RRT associated with VA-ECMO up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.