Versailles Hospital Cardiac Arrest Registry

July 18, 2018 updated by: LEGRIEL stephane, Versailles Hospital

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Le Chesnay, France
        • Recruiting
        • CH Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiac arrest requiring Intensive Care Unit Management

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Legriel Stephane, MD, Intensive care unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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