CH Versailles
Le Chesnay, France
Location status: Recruiting
Location contact
Legriel Stephane, MD
CONTACT
Recruiting
NCT Number: 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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Cardiac arrest requiring Intensive Care Unit management
- Age >= 18 years
Exclusion criteria
- Refusal to participate
Treatment and study plan
Primary outcomes
-
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]
Secondary outcomes
-
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]
-
Postanoxic Status Epilepticus
Time frame: 28 days
Postanoxic Status Epilepticus occurence as defined by EEG abnormalities based on the Salzburg Criteria
-
Complications of anticoagulant/ antiplatelet therapies
Time frame: 28 days
Any bleeding requiring >2 Units Red Blood Cell transfusion
-
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).
-
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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Versailles Hospital
Other
Registry information
Important dates
- Study start
- 2006
- Primary completion
- 2026
- Study completion
- 2030
- First posted
- Jul 20, 2018
- Registry last updated
- Jul 20, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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