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

March 29, 2021 updated by: University Hospital, Strasbourg, France

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

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Strasbourg, France, 67091
        • Recruiting
        • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg are included in this study. Those patients are retrieved thanks to the Software ICCA.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2020

Primary Completion (ACTUAL)

December 21, 2020

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (ACTUAL)

December 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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