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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00814814
Other study ID # 14-01-05 A and B (correction)
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 2008
Est. completion date November 2021

Study information

Verified date November 2020
Source Shaare Zedek Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 313
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Hadassah Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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: 10.1 — View Citation

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.resus — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00998140 - Optimizing Resuscitation After Cardiac Arrest in the Community