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

January 3, 2024 updated by: Prof. Dr. Dirk W. Donker, UMC Utrecht
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL
Time Frame: 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)
1 year after admission
Mortality
Time Frame: In-hospital mortality up to 30 days and through study completion, an average of 1 year.
In-hospital mortality up to 30 days and through study completion, an average of 1 year.
Weaning success
Time Frame: In-hospital up to 30 days
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
30 day mortality
Time Frame: 30 days
30 days
60 day mortality
Time Frame: 60 days
60 days
Complications
Time Frame: During ECLS support up to 30 days and 1 year
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
Time Frame: ECLS days up to 30 days and 1 year
Total duration (in days) of ECLS support
ECLS days up to 30 days and 1 year
ICU admission length of stay
Time Frame: ICU days up to 30 days and 1 year
Length of stay (in days) of ICU admission
ICU days up to 30 days and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
St. Antonius Hospital
Leiden University Medical Center
Isala

Investigators

  • Principal Investigator: Dirk W Donker, Professor, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21-604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Our data will be shared with third parties after approval of the Principle Investigator (in consideration with the participating centers). The criteria and time period will be determined on a case-by case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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