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Protein S100 Beta as a Predictor of Resuscitation Outcome

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00814814
Collaborator
(none)
313
Enrollment
2
Locations
165
Duration (Months)
156.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Management of cardiac arrest is complicated by the lack of a readily available tool identifying individuals who are likely to be successfully resuscitated. S100 beta is a protein that originates in the astroglial cells of the brain, and NSE (Neuron Specific Enolase) is another protein that originates in the neurons themselves. In the laboratory, the concentration of these proteins correlate with evidence of brain damage after head trauma, stroke and exposure to low levels of oxygen. The concentration of these proteins in the blood of human survivors of cardiopulmonary resuscitation in humans is much higher than in patients who were resuscitated but did not survive. However, it is still unclear whether survivors from cardiopulmonary resuscitation have higher levels of these proteins in their blood if they survive with neurological injury secondary to the arrest and resuscitation.

Hypothesis: In humans, the blood concentrations of protein S100 beta and NSE during and after resuscitation can predict who will die despite cardiopulmonary resuscitation and who will survive with neurological injury secondary to the arrest and resuscitation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    313 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Protein S100 Beta as a Predictor of the Outcome of Cardiopulmonary Resuscitation
    Study Start Date :
    Feb 1, 2008
    Anticipated Primary Completion Date :
    Nov 1, 2021
    Anticipated Study Completion Date :
    Nov 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Cardiopulmonary arrest

    Outcome Measures

    Primary Outcome Measures

    1. Poor versus good patient outcome at discharge was used to test the study hypotheses of improved prediction attributable to S100B and NSE concentration. [within 24 hours of discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
    Exclusion Criteria:

    • Patients with do-not-resuscitate orders or an advance directive to that effect.

    • Patients with intracranial hemorrhage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shaare Zedek Medical Center Jerusalem Israel 91031
    2 Hadassah Medical Center Jerusalem Israel 91120

    Sponsors and Collaborators

    • Shaare Zedek Medical Center

    Investigators

    • Principal Investigator: Sharon Einav, MD, Shaare Zedek Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Sharon Einav, Dr., Shaare Zedek Medical Center
    ClinicalTrials.gov Identifier:
    NCT00814814
    Other Study ID Numbers:
    • 14-01-05 A and B (correction)
    First Posted:
    Dec 25, 2008
    Last Update Posted:
    Nov 16, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Nov 16, 2020