Clinical trial NCT05444764: PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
Official title: PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extracorporeal Membrane Oxygenation
Extracorporeal Membrane Oxygenation Complication
Keywords: Extracorporeal life support
Extracorporeal membrane oxygenation
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Erasmus Medical Center
name: St. Antonius Hospital
name: Catharina Ziekenhuis Eindhoven
name: Isala
First posted: 2022-07-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ECLS patients treated at the UMCU (from 2012 onwards) and collaborating centers (May 2021 onwards) will be included.

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.

Eligibility 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)

Primary outcomes:
measure: QoL
timeFrame: 1 year after admission
measure: Mortality
timeFrame: In-hospital mortality up to 30 days and through study completion, an average of 1 year.
measure: Weaning success
timeFrame: In-hospital up to 30 days
Secondary outcomes:
measure: Complications
timeFrame: During ECLS support up to 30 days and 1 year
measure: ECLS support duration
timeFrame: ECLS days up to 30 days and 1 year
measure: ICU admission length of stay
timeFrame: ICU days up to 30 days and 1 year
measure: 30 day mortality
timeFrame: 30 days
measure: 60 day mortality
timeFrame: 60 days
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharinaziekenhuis Eindhoven
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala Hospital
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: Antoniusziekenhuis Nieuwegein
state: Utrecht
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Dirk W Donker, Professor
role: PRINCIPAL_INVESTIGATOR
References: