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Versailles Hospital Cardiac Arrest Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease
Cardiac Arrest

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Years
Official Title: Versailles Hospital Cardiac Arrest Registry
Actual Study Start Date : January 2006
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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]


  2. Postanoxic Status Epilepticus [ Time Frame: 28 days ]
    Postanoxic Status Epilepticus occurence as defined by EEG abnormalities based on the Salzburg Criteria

  3. Complications of anticoagulant/ antiplatelet therapies [ Time Frame: 28 days ]
    Any bleeding requiring >2 Units Red Blood Cell transfusion

  4. 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).

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac arrest requiring Intensive Care Unit Management
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Refusal to participate


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594318


Contacts
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Contact: Legriel Stephane, MD slegriel@ch-versailles.fr

Locations
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France
CH Versailles Recruiting
Le Chesnay, France
Contact: Legriel Stephane, MD         
Sponsors and Collaborators
Versailles Hospital
Investigators
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Study Director: Legriel Stephane, MD Intensive care unit

Additional Information:

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Responsible Party: LEGRIEL stephane, study principal investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03594318    
Other Study ID Numbers: P13/20_ACR
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases