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Versailles Hospital Cardiac Arrest Registry

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ClinicalTrials.gov Identifier: NCT03594318
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
LEGRIEL stephane, Versailles Hospital

Tracking Information
First Submitted Date July 9, 2018
First Posted Date July 20, 2018
Last Update Posted Date July 20, 2018
Actual Study Start Date January 2006
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2018)
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]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 18, 2018)
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Versailles Hospital Cardiac Arrest Registry
Official Title Versailles Hospital Cardiac Arrest Registry
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cardiac arrest requiring Intensive Care Unit Management
Condition Cardiac Arrest
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 18, 2018)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2030
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Cardiac arrest requiring Intensive Care Unit management
  • Age >= 18 years

Exclusion Criteria:

- Refusal to participate

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Legriel Stephane, MD slegriel@ch-versailles.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03594318
Other Study ID Numbers P13/20_ACR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party LEGRIEL stephane, Versailles Hospital
Study Sponsor Versailles Hospital
Collaborators Not Provided
Investigators
Study Director: Legriel Stephane, MD Intensive care unit
PRS Account Versailles Hospital
Verification Date July 2018