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

• Conditions: Veno-arterial Extra-Corporeal Membrane Oxygenation; Health Related Quality of Life

• Registration Number: NCT04653298
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2020-12-21
• Primary Completion: 2020-12-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of health-related quality of life after veino-arterial ECMO	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 Outcome Measures

Name	Time	Method
Analysis by subgroup according to the cardiogenic shock etiology	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
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	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
Evaluation of the current comorbidities thanks to Groll index	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

Trial Locations

Locations (1)

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France