PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

Study Overview
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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: 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.

Official Title
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PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

Conditions
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Extracorporeal Membrane Oxygenation, Extracorporeal Membrane Oxygenation Complication

Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1 year after admission | 
| Mortality |  | 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 | In-hospital up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Incidence of complications (infection, thrombosis, bleeding, respiratory and cardiovascular complications, mechanical complications, neurological complications) | During ECLS support up to 30 days and 1 year | 
| ECLS support duration | Total duration (in days) of ECLS support | ECLS days up to 30 days and 1 year | 
| ICU admission length of stay | Length of stay (in days) of ICU admission | ICU days up to 30 days and 1 year | 
| 30 day mortality |  | 30 days | 
| 60 day mortality |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal life support, Extracorporeal membrane oxygenation