Cost-effectiveness of Extracorporeal Life Support Treatment

September 24, 2019 updated by: Willem Dieperink, University Medical Center Groningen

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

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

Study Overview

Status

Unknown

Conditions

Critically Ill

Intervention / Treatment

Behavioral: Health related Quality of life EQ-5D

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

Netherlands
- - Groningen, Netherlands, 9700 RB
    - Recruiting
    - University Medical Center Groningen
    - Contact:
      
      Wim Dieperink, PhD
      
      Phone Number: +31503619838
      
      Email: w.dieperink@umcg.nl
    - Principal Investigator:
      
      Walter m van den Bergh, MD, PhD

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critically ill patients on the ICU treated with extracorporeal life support

Description

Inclusion Criteria:

Admitted to intensive care
Treated with extracorporeal life support

Exclusion Criteria:

none

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
health related quality of life Time Frame: 12 months	health related quality of life with EQ-5D questionnaire at 6 and 12 months	12 months

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

Principal Investigator: walter m van den Bergh, MD, PhD, department of critical care, UMCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Oude Lansink-Hartgring A, Dos Reis Miranda D, Donker DW, Maas JJ, Delnoij T, Kuijpers M, van den Brule J, Scholten E, Endeman H, Vlaar APJ, van den Bergh WM; Dutch ECLS study group. Cost-effectiveness in extracorporeal life support in critically ill adults in the Netherlands. BMC Health Serv Res. 2018 Mar 9;18(1):172. doi: 10.1186/s12913-018-2964-6.

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)

December 1, 2017

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria