NCT04601896

Brief Summary

If the ExtraCorporeal Membrane Oxygenation (ECMO) improves survival in the management of refractory cardiac arrest (RCA), this technique is still an invasive technique, not devoid of complications and requiring intensive care that can have serious consequences for patients. If the studies so far show an acceptable quality of life post ECMO in refractory cardiac arrest, the study looks about the quality of life of our patients in Grenoble who survived a refractory cardiac arrest between 2006 and 2018 at the hospital university Grenoble Alps and the factors influencing this quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2021

Completed
Last Updated

April 30, 2021

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

October 13, 2020

Last Update Submit

April 27, 2021

Conditions

Keywords

ExtraCorporeal Membrane Oxygenation (ECMO)Refractory Cardiac ArrestQuality life assessement (SF36 QUESTIONNAIRE)

Outcome Measures

Primary Outcomes (1)

  • Global quality of life score

    Items from the SF36 (Short Form 36) survey

    Through study completion, an average of 3 months

Secondary Outcomes (4)

  • Live patients characteristics description

    Through study completion, an average of 3 months

  • Vital status

    Through study completion, an average of 3 months

  • Quality of life score related at live patients characteristics description

    Through study completion, an average of 3 months

  • Quality of life score comparison

    Through study completion, an average of 3 months

Study Arms (2)

Live patients admitted for Refractory Cardiac Arrest with ECMO

Other: SF36 questionnaire via telephone interview

Live patients quality of life admitted for Refractory Cardiac Arrest without ECMO

Other: SF36 questionnaire via telephone interview

Interventions

SF36 questionnaire via telephone interview

Live patients admitted for Refractory Cardiac Arrest with ECMOLive patients quality of life admitted for Refractory Cardiac Arrest without ECMO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

monocentric study based on clinical data and quality of life assessement, Retrospective step : * Clinical data collection for live patients admissed for Refractory Cardiac Arrest with ECMO from january 2006 through december 2018, * Clinical data collection for live patients admissed for Refractory Cardiac Arrest without ECMO from january 2015 through december 2018, Prospective step: * Quality of life assessment via telephone interview based on SF36 questionnaire performed for live patients admissed for Refractory Cardiac Arrest with ECMO from january 2006 through december 2018 * Quality of life assessment via telephone interview based on SF36 questionnaire performed for live patients admissed for Refractory Cardiac Arrest without ECMO from january 2015 through december 2018

You may qualify if:

  • Adult \>18 years
  • Admission to intensive care unit after a Refractory Cardiac Arrest
  • Hemodynamic instability after resumption of spontaneous cardiac activity.
  • Non-opposition of the patient or his relatives
  • Admission to intensive care unit From 2006 Through 2018

You may not qualify if:

  • ECMO for hypothermia or drug intoxication.
  • Comorbidity contraindicated the ECMO
  • Patients dead before hospital discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 26, 2020

Study Start

October 16, 2020

Primary Completion

January 15, 2021

Study Completion

April 27, 2021

Last Updated

April 30, 2021

Record last verified: 2020-12

Locations