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Protein S100 Beta as a Predictor of Resuscitation Outcome

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814814
First Posted: December 25, 2008
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Sharon Einav, Shaare Zedek Medical Center
  Purpose

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
Cardiopulmonary Arrest Outcome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: Protein S100 Beta as a Predictor of the Outcome of Cardiopulmonary Resuscitation

Resource links provided by NLM:


Further study details as provided by Dr Sharon Einav, Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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

Enrollment: 313
Study Start Date: August 2008
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiopulmonary arrest

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814814


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

Publications:
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 Submitted: December 24, 2008
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