Predicting outcomes for patients on extracorporeal life support
PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
UMC Utrecht · NCT05444764
This study is trying to create a tool to help doctors predict how well patients will do a year after they receive extracorporeal life support for serious heart or breathing problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht (other) |
| Locations | 6 sites (Eindhoven, Noord-Brabant and 5 other locations) |
| Trial ID | NCT05444764 on ClinicalTrials.gov |
What this trial studies
This observational multicenter study aims to develop a prediction tool for survival and quality of life outcomes one year after patients receive extracorporeal life support (ECLS) for severe cardiac, circulatory, or respiratory failure. It will also investigate the relationship between left ventricular unloading and the duration of ECLS support, as well as identify predictors of weaning failure from ECLS. The data collected may be reused for future studies to enhance patient care and treatment strategies involving ECLS.
Who should consider this trial
Good fit: Ideal candidates include patients who have received VA and/or VV ECLS for refractory cardiac, circulatory, or respiratory failure.
Not a fit: Patients under 18 years of age or those whose ECLS was limited to cardiac surgery in the operating room or catheterization laboratory may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection and management, potentially reducing mortality and morbidity associated with ECLS.
How similar studies have performed: Other studies have shown promise in improving outcomes with similar predictive approaches in ECLS, but this specific methodology is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Eindhoven, Noord-Brabant and 5 other locations
- Catharinaziekenhuis Eindhoven — Eindhoven, Noord-Brabant, Netherlands (RECRUITING)
- Isala Hospital — Zwolle, Overijssel, Netherlands (NOT_YET_RECRUITING)
- Antoniusziekenhuis Nieuwegein — Nieuwegein, Utrecht, Netherlands (RECRUITING)
- Leids Universitair Medisch Centrum — Leiden, Zuid-Holland, Netherlands (RECRUITING)
- Erasmus Medisch Centrum — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
- UMC Utrecht — Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Dirk W Donker, Professor — UMC Utrecht
- Study coordinator: Lara CA Pladet, MSc
- Email: c.l.a.pladet@umcutrecht.nl
- Phone: +31615466210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Extracorporeal Membrane Oxygenation, Extracorporeal Membrane Oxygenation Complication, Extracorporeal life support, Extracorporeal membrane oxygenation