PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
- Conditions
- Extracorporeal Membrane Oxygenation ComplicationExtracorporeal Membrane Oxygenation
- Registration Number
- NCT05444764
- Lead Sponsor
- UMC Utrecht
- Brief 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. 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:
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Having received (VA and/or VV) ECLS
- All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)
- Surgical and medical patients
- < 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality In-hospital mortality up to 30 days and through study completion, an average of 1 year. Weaning success In-hospital up to 30 days 30 day survival without left ventricular assist device, heart transplantation or short Term mechanical support
QoL 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)
- Secondary Outcome Measures
Name Time Method ICU admission length of stay ICU days up to 30 days and 1 year Length of stay (in days) of ICU admission
Complications During ECLS support up to 30 days and 1 year Incidence of complications (infection, thrombosis, bleeding, respiratory and cardiovascular complications, mechanical complications, neurological complications)
ECLS support duration ECLS days up to 30 days and 1 year Total duration (in days) of ECLS support
30 day mortality 30 days 60 day mortality 60 days
Trial Locations
- Locations (6)
Catharinaziekenhuis Eindhoven
🇳🇱Eindhoven, Noord-Brabant, Netherlands
Isala Hospital
🇳🇱Zwolle, Overijssel, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Leids Universitair Medisch Centrum
🇳🇱Leiden, Zuid-Holland, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Antoniusziekenhuis Nieuwegein
🇳🇱Nieuwegein, Utrecht, Netherlands