PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

NCT ID: NCT05444764

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-16

Study Completion Date

2024-03-01

Brief Summary

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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

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This observational multicenter study was designed to serve the following objectives:

1. 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
2. Study the association between application of left ventricular unloading and ECLS support duration and weanability
3. 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.

Conditions

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Extracorporeal Membrane Oxygenation Extracorporeal Membrane Oxygenation Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Having received (VA and/or VV) ECLS
* All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)
* Surgical and medical patients

Exclusion Criteria

* \< 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Isala

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Dirk W. Donker

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dirk W Donker, Professor

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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Catharinaziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status RECRUITING

Isala Hospital

Zwolle, Overijssel, Netherlands

Site Status NOT_YET_RECRUITING

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Site Status RECRUITING

Erasmus Medisch Centrum

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Antoniusziekenhuis Nieuwegein

Nieuwegein, Utrecht, Netherlands

Site Status RECRUITING

UMC Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Lara CA Pladet, MSc

Role: CONTACT

+31615466210

Dirk W Donker, Professor

Role: CONTACT

+31 (0)65017721

Facility Contacts

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Leon Montenij, MSc

Role: primary

040 239 8501

Luuk Ottenspoor, Dr

Role: backup

040 239 9111

Marijn Kuijpers, MD

Role: primary

038 424 5000

Laurien Koppenhagen, van, MD

Role: backup

038 424 5000

Carlos E Kraemer, MSc

Role: primary

71 526 5018

Jacinta J Maas, MSc

Role: backup

71 526 5018

Christiaan L Meuwese, Dr.

Role: primary

010 704 0704

Erik Scholten, MSc

Role: primary

0515 - 48 88 88

Peter Noorzij, Dr.

Role: backup

0515 - 48 88 88

Lara CA Pladet, MSc

Role: primary

+31615466210

Dirk W Donker, Professor

Role: backup

Other Identifiers

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21-604

Identifier Type: -

Identifier Source: org_study_id

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