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NCT02837419 Clinical Trial

Cost-effectiveness of Extracorporeal Life Support Treatment

Critically Ill Clinical Trial

Official title:
A Multicenter Prospective Observational Cohort Study Determining the Cost-effectiveness of Extracorporal Life Support (ECLS) Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02837419
Other study ID # Dutch ECLS/2014/QoL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date January 1, 2020

Study information
Verified date September 2019
Source University Medical Center Groningen
Contact Wim Dieperink, PhD
Phone +31503619838
Email w.dieperink@umcg.nl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study evaluates patients on ECLS treatment as considered appropriate with mortality and health related Quality of life and costs.

Description:

A direct comparison between usual care and ECLS treatment is difficult. Alternatively we compare predicted mortality for every patient based on validated scoring systems at the initiation of ECLS treatment with the actual outcome, so every patient is his own control.

Primary outcome is HRQoL assessed with the EQ-5D questionnaire at 1 year. Healthcare costs and costs from a societal perspective are prospectively measured.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Admitted to intensive care

- Treated with extracorporeal life support

Exclusion Criteria:

- none

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Health related Quality of life EQ-5D
Quality of Care

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary health related quality of life health related quality of life with EQ-5D questionnaire at 6 and 12 months 12 months
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