Protein S100 Beta as a Predictor of Resuscitation Outcome

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Cardiopulmonary Arrest Outcome

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 :	August 2008
Estimated Primary Completion Date :	March 2019
Estimated Study Completion Date :	September 2020

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Cardiopulmonary arrest

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. [ Time Frame: within 24 hours of discharge ]

Biospecimen Retention:   Samples With DNA

Blood

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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.

Criteria

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Hadassah Medical Center
Jerusalem, Israel, 91120

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators

Principal Investigator:	Sharon Einav, MD	Shaare Zedek Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Einav S, Kaufman N, Algur N, Strauss-Liviatan N, Kark JD. Brain biomarkers and management of uncertainty in predicting outcome of cardiopulmonary resuscitation: a nomogram paints a thousand words. Resuscitation. 2013 Aug;84(8):1083-8. doi: 10.1016/j.resuscitation.2013.01.031. Epub 2013 Feb 4.

Einav S, Kaufman N, Algur N, Kark JD. Modeling serum biomarkers S100 beta and neuron-specific enolase as predictors of outcome after out-of-hospital cardiac arrest: an aid to clinical decision making. J Am Coll Cardiol. 2012 Jul 24;60(4):304-11. doi: 10.1016/j.jacc.2012.04.020.

Responsible Party:	Dr Sharon Einav, Dr., Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00814814 History of Changes
Other Study ID Numbers:	14-01-05 A and B (correction)
First Posted:	December 25, 2008
Last Update Posted:	April 28, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Additional relevant MeSH terms:

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Protein S; Anticoagulants