NCT03594318

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2006Dec 2030

Study Start

First participant enrolled

January 1, 2006

Completed
12.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

20.9 years

First QC Date

July 9, 2018

Last Update Submit

July 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Long term favorable outcome

    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 Outcomes (5)

  • Short term favorable outcome

    3 months

  • Postanoxic Status Epilepticus

    28 days

  • Complications of anticoagulant/ antiplatelet therapies

    28 days

  • Short term quality of life as assessed by the Short Form (36) Health Survey (SF36)

    3 months

  • Long term quality of life as assessed by the Short Form (36) Health Survey (SF36)

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac arrest requiring Intensive Care Unit Management

You may qualify if:

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

You may not qualify if:

  • \- Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Versailles

Le Chesnay, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Legriel Stephane, MD

    Intensive care unit

    STUDY DIRECTOR

Central Study Contacts

Legriel Stephane, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
study principal investigator

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 20, 2018

Study Start

January 1, 2006

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2030

Last Updated

July 20, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations