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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04653298
Enrollment
300
Registered
2020-12-04
Start date
2020-12-21
Completion date
2021-12-31
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHEREvaluation 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.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of health-related quality of life after veino-arterial ECMOThe quality of life will be evaluated from 1 to 12 years after the ECMOQuality of life will be evaluated by Short Form 36 ( score 0 to 100)

Secondary

MeasureTime frameDescription
Analysis by subgroup according to the cardiogenic shock etiologyThe quality of life will be evaluated from 1 to 12 years after the ECMO5 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 lifeThe quality of life will be evaluated from 1 to 12 years after the ECMO5 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 indexThe quality of life will be evaluated from 1 to 12 years after the ECMO5 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026