Refractory Cardiac ArrestAQUANCT04601896
Evaluation of Quality of Life and Its Influencing Factors After VA-ECMO in Refractory Cardiac Arrest Based on SF-36 Score : A Grenoble Cohort Study From 2006 Through 2018
An observational study of Refractory Cardiac Arrest and ExtraCorporeal Membrane Oxygenation (ECMO), run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Cardiac Arrest, ExtraCorporeal Membrane Oxygenation (ECMO)
- What is being tested?
- SF36 questionnaire via telephone interview
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2020to 27 Apr 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- ECMO for hypothermia or drug intoxication.
- Comorbidity contraindicated the ECMO
- Patients dead before hospital discharge
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- SF36 questionnaire via telephone interview
- Keywords
- ExtraCorporeal Membrane Oxygenation (ECMO), Refractory Cardiac Arrest, Quality life assessement (SF36 QUESTIONNAIRE)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF36 questionnaire via telephone interviewOther
SF36 questionnaire via telephone interview
| Study group | Role | What they receive |
|---|---|---|
| Live patients admitted for Refractory Cardiac Arrest with ECMO | Not described Receives: Other: SF36 questionnaire via telephone interview | |
| Live patients quality of life admitted for Refractory Cardiac Arrest without ECMO | Not described Receives: Other: SF36 questionnaire via telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global quality of life score
Items from the SF36 (Short Form 36) survey
Measured: Through study completion, an average of 3 months
Secondary outcomes (4)
Live patients characteristics description
Demographic and clinical retrospective data collection
Measured: Through study completion, an average of 3 months
Vital status
Deed/Lived
Measured: Through study completion, an average of 3 months
Quality of life score related at live patients characteristics description
Items from the SF36 (Short Form 36) survey matched with live patients characteristics description
Measured: Through study completion, an average of 3 months
Quality of life score comparison
Items from the SF36 (Short Form 36) survey compared between the 2 groups ( RCA with /without ECMO) admitted from january 2015 and december 2018
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start16 Oct 2020
- Primary completion15 Jan 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601896
- Sponsor's protocol ID
- 38RC20.225
- Other IDs
- 2020-A01859-30
- Acronym
- AQUA
- Status last verified
- Dec 2020
- First submitted
- 13 Oct 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Life and Its Influencing Factors After VA-ECMO in Refractory Cardiac Arrest Based on SF-36 Score : A Grenoble Cohort Study From 2006 Through 2018
- ClinicalTrials.gov ID
- NCT04601896
- Acronym / sponsor ID
- AQUA / 38RC20.225
- Keywords
- ExtraCorporeal Membrane Oxygenation (ECMO), Refractory Cardiac Arrest, Quality life assessement (SF36 QUESTIONNAIRE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- ECMO for hypothermia or drug intoxication.
- Comorbidity contraindicated the ECMO
- Patients dead before hospital discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SF36 questionnaire via telephone interviewSF36 questionnaire via telephone interview | Other | Live patients admitted for Refractory Cardiac Arrest with ECMO, Live patients quality of life admitted for Refractory Cardiac Arrest without ECMO |
Primary outcome
Global quality of life score
Time frame: Through study completion, an average of 3 months
Items from the SF36 (Short Form 36) survey
4 secondary outcomes
Live patients characteristics description
Time frame: Through study completion, an average of 3 months
Vital status
Time frame: Through study completion, an average of 3 months
Quality of life score related at live patients characteristics description
Time frame: Through study completion, an average of 3 months
Quality of life score comparison
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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Refractory Cardiac Arrest
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Cardiac Arrest and ExtraCorporeal Membrane Oxygenation (ECMO), run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global quality of life score (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.