- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04653298
Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation Which is a Salvage Therapy Used in Patients With Severe Respiratory or Cardiac Failure Who Have Not Responded to Maximal Conventional Medical Therapy
Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Strasbourg, France, 67091
- Recruiting
- Les Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Quality of life will be evaluated by Short Form 36 ( score 0 to 100)
|
The quality of life will be evaluated from 1 to 12 years after the ECMO
|
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)
|
The quality of life will be evaluated from 1 to 12 years after the ECMO
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis by subgroup according to the cardiogenic shock etiology
Time Frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
|
5 subgroups will be assessed according to the cardiogenic shock etiology: post cardiac surgery, post cardiac ischemia, pulmonary embolism or other right ventricle dysfunction, other 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
Time Frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
|
5 subgroups will be assessed according to the cardiogenic shock etiology: post cardiac surgery, post cardiac ischemia, pulmonary embolism or other right ventricle dysfunction, other etiology
|
The quality of life will be evaluated from 1 to 12 years after the ECMO
|
Evaluation of the current comorbidities thanks to Groll index
Time Frame: The quality of life will be evaluated from 1 to 12 years after the ECMO
|
5 subgroups will be assessed according to the cardiogenic shock etiology: post cardiac surgery, post cardiac ischemia, pulmonary embolism or other right ventricle dysfunction, other etiology
|
The quality of life will be evaluated from 1 to 12 years after the ECMO
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 7951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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