Protein S100 Beta as a Predictor of Resuscitation Outcome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr Sharon Einav, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00814814
First received: December 24, 2008
Last updated: May 30, 2015
Last verified: May 2015
  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
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 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 313
Study Start Date: August 2008
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiopulmonary arrest

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814814

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Sharon Einav, MD Shaare Zedek Medical Center
  More Information

No publications provided by Shaare Zedek Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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)
Study First Received: December 24, 2008
Last Updated: May 30, 2015
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 29, 2015