PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

UMC Utrecht800 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Extracorporeal Membrane Oxygenation Extracorporeal Membrane Oxygenation Complication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

Catharinaziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

RECRUITING

Isala Hospital

Zwolle, Overijssel, Netherlands

NOT_YET_RECRUITING

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Outcomes

Primary Outcomes

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)

Time frame: 1 year after admission

Mortality

Time frame: 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

Time frame: In-hospital up to 30 days

Secondary Outcomes

Complications

Incidence of complications (infection, thrombosis, bleeding, respiratory and cardiovascular complications, mechanical complications, neurological complications)

Time frame: During ECLS support up to 30 days and 1 year

ECLS support duration

Total duration (in days) of ECLS support

Time frame: ECLS days up to 30 days and 1 year

ICU admission length of stay

Length of stay (in days) of ICU admission

Time frame: ICU days up to 30 days and 1 year

30 day mortality

Time frame: 30 days

60 day mortality