Clinical trial NCT00814814: Protein S100 Beta as a Predictor of Resuscitation Outcome
Official title: Protein S100 Beta as a Predictor of the Outcome of Cardiopulmonary Resuscitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiopulmonary Arrest Outcome
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-12-25
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility 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

Primary outcomes:
measure: Poor versus good patient outcome at discharge was used to test the study hypotheses of improved prediction attributable to S100B and NSE concentration.
timeFrame: within 24 hours of discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Sharon Einav, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.resuscitation.2013.01.031. Epub 2013 Feb 4.
citation: 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.