PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS (PRECISE - ECLS)

UMC Utrecht

Status: Enrolling

Conditions: Extracorporeal Membrane Oxygenation Complication; Extracorporeal Membrane Oxygenation

Study type: Observational

Funder types: Other

Identifiers

NCT05444764

21-604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)