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Clinical Trials/NCT04653298
NCT04653298
Unknown
Not Applicable

Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation

University Hospital, Strasbourg, France1 site in 1 country300 target enrollmentDecember 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Veno-arterial Extra-Corporeal Membrane Oxygenation
Sponsor
University Hospital, Strasbourg, France
Enrollment
300
Locations
1
Primary Endpoint
Evaluation of health-related quality of life after veino-arterial ECMO
Last Updated
5 years ago

Overview

Brief Summary

Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. The aim of this study is to evaluate the Health-related quality of life in adults after veino-arterial Extra-Corporeal Membrane Oxygenation. The quality of life will be evaluated thanks to several methods : the Short Form 36, the EQ 5D 5L and the return to work status.

Then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. The investigators will also evaluate current comorbidities of the patient thanks to the Groll Index.

Registry
clinicaltrials.gov
Start Date
December 21, 2020
End Date
December 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults \>18 years
  • Veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg
  • Affiliated to the French social security system

Exclusion Criteria

  • Patients under guardianship or with legal protection

Outcomes

Primary Outcomes

Evaluation of health-related quality of life after veino-arterial ECMO

Time Frame: The quality of life will be evaluated from 1 to 12 years after the ECMO

EQ 5D 5L ( description of mobility, personal autonomy, routine activities, pain and discomfort, anxiety and depression and an analog visual scale)

Secondary Outcomes

  • Analysis by subgroup according to the cardiogenic shock etiology(The quality of life will be evaluated from 1 to 12 years after the ECMO)
  • Research of risk factors of an altered quality of life(The quality of life will be evaluated from 1 to 12 years after the ECMO)
  • Evaluation of the current comorbidities thanks to Groll index(The quality of life will be evaluated from 1 to 12 years after the ECMO)

Study Sites (1)

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