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Cost-effectiveness of Extracorporeal Life Support Treatment

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ClinicalTrials.gov Identifier: NCT02837419
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Willem Dieperink, University Medical Center Groningen

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

Condition or disease Intervention/treatment
Critically Ill 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: A Multicenter Prospective Observational Cohort Study Determining the Cost-effectiveness of Extracorporal Life Support (ECLS) Treatment
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

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


Primary Outcome Measures :
  1. health related quality of life [ Time Frame: 12 months ]
    health related quality of life with EQ-5D questionnaire at 6 and 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients on the ICU treated with extracorporeal life support
Criteria

Inclusion Criteria:

  • Admitted to intensive care
  • Treated with extracorporeal life support

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837419


Contacts
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Contact: Wim Dieperink, PhD +31503619838 ext 49838 w.dieperink@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Wim Dieperink, PhD    +31503619838    w.dieperink@umcg.nl   
Principal Investigator: Walter m van den Bergh, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: walter m van den Bergh, MD, PhD department of critical care, UMCG
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Willem Dieperink, research coordinator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02837419    
Other Study ID Numbers: Dutch ECLS/2014/QoL
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by Willem Dieperink, University Medical Center Groningen:
extracorporeal life support
health related quality of life
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes