Extracorporeal Membrane OxygenationPRECISE - ECLSNCT05444764
PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
An observational study of Extracorporeal Membrane Oxygenation and Extracorporeal Membrane Oxygenation Complication, run by UMC Utrecht at 6 sites in Netherlands.
Trial summary
Extracorporeal life support (ECLS) is used as a last resort intervention in patients with severe cardiac, circulatory and/or respiratory failure with high (>80%) expected mortality. Despite considerable improvements in patient selection and outcomes, mortality and morbidity after ECLS remain high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Extracorporeal Membrane Oxygenation Complication
- How many people
- 800 participants
- Where
- 6 sitesNetherlands
- Study dates
- 16 Sep 2021to 1 Mar 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All ECLS patients treated at the UMCU (from 2012 onwards) and collaborating centers (May 2021 onwards) will be included.
Who may be able to join
- Having received (VA and/or VV) ECLS
- All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)
- Surgical and medical patients
Who cannot join
- < 18 years of age
- ECLS confined to cardiac surgery in the operating room (OR) or in the catheterization laboratory
- Objection against use of clinical data (opt-out principle)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Catharinaziekenhuis Eindhoven
Eindhoven, North Brabant, 5623EJ
Leon Montenij, MSc, 040 239 8501, leon.montenij@catharinaziekenhuis.nl
Luuk Ottenspoor, Dr, 040 239 9111, luuk.ottenspoor@catharinaziekenhuis.nl
- Recruiting
Leids Universitair Medisch Centrum
Leiden, South Holland, 2300 RC
Carlos E Kraemer, MSc, 71 526 5018, c.v.elzo_kraemer@lumc.nl
Jacinta J Maas, MSc, 71 526 5018, j.j.maas@lumc.nl
- Recruiting
Antoniusziekenhuis Nieuwegein
Nieuwegein, Utrecht, 3435CM
Erik Scholten, MSc, 0515 - 48 88 88, e.scholten@antoniusziekenhuis.nl
Peter Noorzij, Dr., 0515 - 48 88 88, p.noordzij@antoniusziekenhuis.nl
- Recruiting
Erasmus Medisch Centrum
Rotterdam, South Holland, 3015GD
Christiaan L Meuwese, Dr., 010 704 0704, c.meuwese@erasmusmc.nl
- Recruiting
UMC Utrecht
Utrecht, 3584CX
Lara CA Pladet, MSc, +31615466210, c.l.a.pladet@umcutrecht.nl
Dirk W Donker, Professor, d.w.donker@umcutrecht.nl
- Not yet recruiting
Isala Hospital
Zwolle, Overijssel, 8025 AB
Marijn Kuijpers, MD, 038 424 5000, m.kuijpers@isala.nl
Laurien Koppenhagen, van, MD, 038 424 5000, l.van.koppenhagen@isala.nl
About this study
Extracorporeal life support (ECLS) is used as a last resort intervention in patients with severe cardiac, circulatory and/or respiratory failure with high (>80%) expected mortality. Despite considerable improvements in patient selection and outcomes, mortality and morbidity after ECLS remain high. An improved selection and management of patients who are supported with ECLS is therefore unquestionably needed from a perspective of optimal patient care and the socio-economic impact of this costly intervention.
Read the detailed description
This observational multicenter study was designed to serve the following objectives:
- Develop a (dynamic) prediction tool for survival and quality of life outcomes 1 year after ECLS support for the situation at baseline and 7 days after ECLS initiation
- Study the association between application of left ventricular unloading and ECLS support duration and weanability
- Description of the incidence of VA ECLS weaning failure and identification of predictors for VA ECLS weaning failure
Under this umbrella research protocol, the data collected by this observational multicenter study can also be reused for potential novel substudies with the objective to improve the quality of care and the efficiency of current treatment strategies involving ECLS.
- Keywords
- Extracorporeal life support, Extracorporeal membrane oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL
By the EuroQol EQ-5D, an instrument to measure health related quality of life. It assesses health in five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression, ranging from 1 to 3 in each domain (e.g. from 1 'I am not anxious or depressed' to 3 'I am extremely anxious or depressed' in the anxiety/depression domain) finding 243 unique health states. These health states can be converted into an index ranging from 0 (death) to 1 (perfect health)
Measured: 1 year after admission
Mortality
Measured: In-hospital mortality up to 30 days and through study completion, an average of 1 year.
Weaning success
30 day survival without left ventricular assist device, heart transplantation or short Term mechanical support
Measured: In-hospital up to 30 days
Secondary outcomes (5)
Complications
Incidence of complications (infection, thrombosis, bleeding, respiratory and cardiovascular complications, mechanical complications, neurological complications)
Measured: During ECLS support up to 30 days and 1 year
ECLS support duration
Total duration (in days) of ECLS support
Measured: ECLS days up to 30 days and 1 year
ICU admission length of stay
Length of stay (in days) of ICU admission
Measured: ICU days up to 30 days and 1 year
30 day mortality
Measured: 30 days
60 day mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start16 Sep 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Erasmus Medical Center, St. Antonius Hospital, Catharina Ziekenhuis Eindhoven, Isala
- Responsible party
- Principal investigator, Prof. Dr. Dirk W. Donker, UMC Utrecht
- Investigators
- Dirk W Donker, Professor, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444764
- Sponsor's protocol ID
- 21-604
- Acronym
- PRECISE - ECLS
- Status last verified
- Dec 2023
- First submitted
- 22 Jun 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our data will be shared with third parties after approval of the Principle Investigator (in consideration with the participating centers). The criteria and time period will be determined on a case-by case basis.
Publications
van Steenwijk MPJ, Uitbeijerse LP, Pladet LCA, van Esch A, Taverne Y, Donker DW, Elzo Kraemer CV, Maas JJ, Kimman JR, Dubois EA, Constantinescu AA, van Rosmalen J, Gommers D, van Mieghem NM, de Boer RA, Meuwese CL; Dutch ECLS Study Group. Association Between Preadmission beta-Blocker Use and Venoarterial Extracorporeal Membrane Oxygenation Weaning Failure in Patients With Cardiogenic Shock. J Am Heart Assoc. 2026 Jun 2;15(11):e046530. doi: 10.1161/JAHA.125.046530. Epub 2026 May 25.
PubMed 42179258
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
- ClinicalTrials.gov ID
- NCT05444764
- Acronym / sponsor ID
- PRECISE - ECLS / 21-604
- Keywords
- Extracorporeal life support, Extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Erasmus Medical Center, St. Antonius Hospital, Catharina Ziekenhuis Eindhoven, Isala
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 6 Jul 2022 (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 life support (ECLS) is used as a last resort intervention in patients with severe cardiac, circulatory and/or respiratory failure with high (>80%) expected mortality. Despite considerable improvements in patient selection and outcomes, mortality and morbidity after ECLS remain high. An improved selection and management of patients who are supported with ECLS is therefore unquestionably needed from a perspective of optimal patient care and the socio-economic impact of this costly intervention.
Detailed description
This observational multicenter study was designed to serve the following objectives:
- Develop a (dynamic) prediction tool for survival and quality of life outcomes 1 year after ECLS support for the situation at baseline and 7 days after ECLS initiation
- Study the association between application of left ventricular unloading and ECLS support duration and weanability
- Description of the incidence of VA ECLS weaning failure and identification of predictors for VA ECLS weaning failure
Under this umbrella research protocol, the data collected by this observational multicenter study can also be reused for potential novel substudies with the objective to improve the quality of care and the efficiency of current treatment strategies involving ECLS.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ECLS patients treated at the UMCU (from 2012 onwards) and collaborating centers (May 2021 onwards) will be included.
Key inclusion criteria (3 listed)
- Having received (VA and/or VV) ECLS
- All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)
- Surgical and medical patients
Key exclusion criteria (3 listed)
- < 18 years of age
- ECLS confined to cardiac surgery in the operating room (OR) or in the catheterization laboratory
- Objection against use of clinical data (opt-out principle)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QoL
Time frame: 1 year after admission
By the EuroQol EQ-5D, an instrument to measure health related quality of life. It assesses health in five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression, ranging from 1 to 3 in each domain (e.g. from 1 'I am not anxious or depressed' to 3 'I am extremely anxious or depressed' in the anxiety/depression domain) finding 243 unique health states. These health states can be converted into an index ranging from 0 (death) to 1 (perfect health)
Mortality
Time frame: In-hospital mortality up to 30 days and through study completion, an average of 1 year.
Weaning success
Time frame: In-hospital up to 30 days
30 day survival without left ventricular assist device, heart transplantation or short Term mechanical support
5 secondary outcomes
Complications
Time frame: During ECLS support up to 30 days and 1 year
ECLS support duration
Time frame: ECLS days up to 30 days and 1 year
ICU admission length of stay
Time frame: ICU days up to 30 days and 1 year
30 day mortality
Time frame: 30 days
60 day mortality
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 42179258van Steenwijk MPJ, Uitbeijerse LP, Pladet LCA, van Esch A, Taverne Y, Donker DW, Elzo Kraemer CV, Maas JJ, Kimman JR, Dubois EA, Constantinescu AA, van Rosmalen J, Gommers D, van Mieghem NM, de Boer RA, Meuwese CL; Dutch ECLS Study Group. Association Between Preadmission beta-Blocker Use and Venoarterial Extracorporeal Membrane Oxygenation Weaning Failure in Patients With Cardiogenic Shock. J Am Heart Assoc. 2026 Jun 2;15(11):e046530. doi: 10.1161/JAHA.125.046530. Epub 2026 May 25.
- Individual participant dataSharing planned: Undecided. Our data will be shared with third parties after approval of the Principle Investigator (in consideration with the participating centers). The criteria and time period will be determined on a case-by case basis.
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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. This study is not recruiting at the moment.
Dirk W Donker, Professor principal investigator
UMC Utrecht
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Extracorporeal Membrane Oxygenation Complication, run by UMC Utrecht at 6 sites in Netherlands.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara CA Pladet, MSc (+31615466210, c.l.a.pladet@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoL (time frame: 1 year after admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444764, which also lists 1 linked publication.
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 5 Jan 2024.