NCT05444764

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

June 22, 2022

Last Update Submit

January 3, 2024

Conditions

Extracorporeal Membrane OxygenationExtracorporeal Membrane Oxygenation Complication

Keywords

Extracorporeal life supportExtracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Complications

    During ECLS support up to 30 days and 1 year

  • ECLS support duration

    ECLS days up to 30 days and 1 year

  • ICU admission length of stay

    ICU days up to 30 days and 1 year

  • 30 day mortality

    30 days

  • 60 day mortality

    60 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All ECLS patients treated at the UMCU (from 2012 onwards) and collaborating centers (May 2021 onwards) will be included.

You may qualify if:

  • Having received (VA and/or VV) ECLS
  • All ECLS indications (refractory cardiac, circulatory and/or respiratory failure)
  • Surgical and medical patients

You may not qualify if:

  • \< 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Catharinaziekenhuis Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

RECRUITING

Isala Hospital

Zwolle, Overijssel, 8025 AB, Netherlands

NOT YET RECRUITING

Leids Universitair Medisch Centrum

Leiden, South Holland, 2300 RC, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Antoniusziekenhuis Nieuwegein

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

UMC Utrecht

Utrecht, 3584CX, Netherlands

RECRUITING

Study Officials

  • Dirk W Donker, Professor

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara CA Pladet, MSc

CONTACT

+31615466210c.l.a.pladet@umcutrecht.nl

Dirk W Donker, Professor

CONTACT

+31 (0)65017721d.w.donker@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 6, 2022

Study Start

September 16, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

January 5, 2024

Record last verified: 2023-12

Locations

NL(6)