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Clinical Trials/NCT00843297
NCT00843297
Completed
Phase 4

Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest

University of Leipzig1 site in 1 country120 target enrollmentApril 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
University of Leipzig
Enrollment
120
Locations
1
Primary Endpoint
Time to reach the target temperature
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.

Detailed Description

Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.

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

Investigators

Sponsor
University of Leipzig

Eligibility Criteria

Inclusion Criteria

  • ROSC after SCA due to VF/VT or PEA/Asystolia

Exclusion Criteria

  • Non-cardiac SCA
  • Pregnancy
  • Unstable Circulation instead of High-dose Inotropics
  • Life-expectancy reducing concomitant illness

Outcomes

Primary Outcomes

Time to reach the target temperature

Time Frame: Twenty-four hours

NSE as a parameter for cerebral damage

Time Frame: Seventy-two hours

Secondary Outcomes

  • Neurologic outcome(Six months)
  • Periprocedural complications(Seventy-two hours)
  • Survival(Six months)

Study Sites (1)

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