- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594318
Versailles Hospital Cardiac Arrest Registry
Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.
Data collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).
On-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Legriel Stephane, MD
- Email: slegriel@ch-versailles.fr
Study Locations
-
-
-
Le Chesnay, France
- Recruiting
- CH Versailles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cardiac arrest requiring Intensive Care Unit management
- Age >= 18 years
Exclusion Criteria:
- Refusal to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long term favorable outcome
Time Frame: 1 year
|
A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview. The CPC score : [5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability] |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short term favorable outcome
Time Frame: 3 months
|
A favorable outcome is defined by a Cerebral Performance Category scale score (CPC) of 1 or 2. The Cerebral Performance Category scale score will be determined according to hospital charts and/or general practitioner phone interview. The CPC score : [5: Death, 4: Persistent vegetative state, 3: Severe disability, 2: Moderate disability, 1 : Low disability] |
3 months
|
Postanoxic Status Epilepticus
Time Frame: 28 days
|
Postanoxic Status Epilepticus occurence as defined by EEG abnormalities based on the Salzburg Criteria
|
28 days
|
Complications of anticoagulant/ antiplatelet therapies
Time Frame: 28 days
|
Any bleeding requiring >2 Units Red Blood Cell transfusion
|
28 days
|
Short term quality of life as assessed by the Short Form (36) Health Survey (SF36)
Time Frame: 3 months
|
Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).
|
3 months
|
Long term quality of life as assessed by the Short Form (36) Health Survey (SF36)
Time Frame: 1 year
|
Description of global SF36 score and each of its eight sections (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Legriel Stephane, MD, Intensive care unit
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P13/20_ACR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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