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Oxidative Stress and Cardiac Arrest

Sponsor
Institut d'Anesthesiologie des Alpes Maritimes (Other)
Overall Status
Completed
CT.gov ID
NCT00888966
Collaborator
(none)
40
Enrollment
1
Location
56
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.

Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.

The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia
    Study Start Date :
    Apr 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Out of hospital cardiac arrest

    Out of hospital cardiac patients successfully resuscitated and admitted to ICU

    Outcome Measures

    Primary Outcome Measures

    1. Oxidative stress markers and antioxidants after out of hospital cardiac arrest [4 days]

    Secondary Outcome Measures

    1. Lactate after out of hospital cardiac arrest [4 days]

    2. Outcome after out of hospital cardiac arrest [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Out of hospital cardiac arrest
    Exclusion Criteria:

    • refractory shock

    • moribund patient

    • resuscitation > 60 minutes

    • hypothermia < 30 degrees

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nice Nice France 06003

    Sponsors and Collaborators

    • Institut d'Anesthesiologie des Alpes Maritimes

    Investigators

    • Study Chair: Carole Ichai, MD, PhD, Centre Hospitalier Universitaire de Nice

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00888966
    Other Study ID Numbers:
    • IAAM 2009-2
    First Posted:
    Apr 28, 2009
    Last Update Posted:
    Jul 4, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    heart arrest
    oxidative stress
    lactic acid
    outcome
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Jul 4, 2011