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Clinical Trials/NCT01102153
NCT01102153
Completed
Not Applicable

NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death

University of Leipzig1 site in 1 country108 target enrollmentApril 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
University of Leipzig
Enrollment
108
Locations
1
Primary Endpoint
neuron specific enolase (NSE) as a parameter for cerebral damage
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

Detailed Description

Consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. NSE was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. Neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
January 2010
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Leipzig

Eligibility Criteria

Inclusion Criteria

  • ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia

Exclusion Criteria

  • Non-cardiac sudden death
  • Pregnancy
  • Unstable circulation with high-dose inotropics
  • Life-expectancy reducing concomitant illness

Outcomes

Primary Outcomes

neuron specific enolase (NSE) as a parameter for cerebral damage

Time Frame: 72 hours

Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.

Secondary Outcomes

  • time to overall survival(one year)
  • neurologic outcome(6 months)

Study Sites (1)

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