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HANOX: Functional Outcome After Cardiac Arrest

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT02292147
Collaborator
(none)
140
Enrollment
1
Location
55.3
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Functional outcome after cerebral anoxia due to cardiac arrest is poorly documented.. Survival after out of hospital cardiac arrest has improved and long term follow up of the patients is not routinely effective. Patients showing sign of awakening very early are considered in a good outcome group. Nevertheless they can experience some restriction and difficulties when they try to return to their premorbid level of functioning.

    We aim to study their long term functional outcome and their level of anxiety, depression, quality of life and caregiver burden as well as their general cognitive functioning. Prognosis factors will be studied in the acute phase.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days
    Actual Study Start Date :
    Mar 13, 2013
    Actual Primary Completion Date :
    Oct 20, 2017
    Actual Study Completion Date :
    Oct 20, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Glasgow outcome Scale Extended score [18 months]

      Functional outcome at 18 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria :

    • age 18 to 85

    • Out of hospital cardiac arrest ; cardiac arrest in the ER is eligible

    • Glasgow Coma Score ≥ 12 within 15 days after onset

    • Living in the parisian area

    Exclusion criteria :

    • no social security

    • Neurological condition (multiple sclerosis, parkinson disease, AMS, stroke) priori to the cardiac arrest

    • Psychiatric condition (schizophrenia, severe bipolar syndrome, long term neuroleptic medication, autistic spectrum disorders

    • Deafness and blindness

    • Neoplasia

    • Premorbid limitation of autonomy.

    • Difficulties in speaking and writing the French language

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pitié salpetriere Hospital Paris France 75013

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Study Director: Anne Peskine, MD, Assistance Publique - Hôpitaux de Paris
    • Principal Investigator: Charles-Edouard Luyt, MD, PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT02292147
    Other Study ID Numbers:
    • P111012
    First Posted:
    Nov 17, 2014
    Last Update Posted:
    Aug 19, 2020
    Last Verified:
    Nov 1, 2017
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Cerebral anoxia
    Functional outcome
    Additional relevant MeSH terms:
    Heart Arrest
    Out-of-Hospital Cardiac Arrest

    Study Results

    No Results Posted as of Aug 19, 2020