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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653298
• Other study ID #: 7951
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Evaluation of quality of life, comorbidities and return to work status
Quality of life will be evaluated thanks to several methods: Short Form 36, EQ 5D 5L and return to work status Questionnaires will be evaluated through postal and phone call at least 12 months after ECMO.

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of health-related quality of life after veino-arterial 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
Primary	Evaluation of health-related quality of life after veino-arterial 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	Analysis by subgroup according to the cardiogenic shock etiology	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
Secondary	Research of risk factors of an altered quality of life	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
Secondary	Evaluation of the current comorbidities thanks to Groll index	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