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Clinical Trials/NCT01083069
NCT01083069
Unknown
Not Applicable

Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation

University of Leipzig1 site in 1 country150 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
University of Leipzig
Enrollment
150
Locations
1
Primary Endpoint
Neurological outcome after 6 month after MIH, Quality of life-survey
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 long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

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).

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
June 2011
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Leipzig

Eligibility Criteria

Inclusion Criteria

  • survived cardiac arrest
  • voluntary consent

Exclusion Criteria

  • no voluntary consent

Outcomes

Primary Outcomes

Neurological outcome after 6 month after MIH, Quality of life-survey

Time Frame: 6 Month

Neurological outcome after 6 month after MIH measured by questionnaire.

Secondary Outcomes

  • Managing daily activities(6 Month)
  • Neurological Outcome in consideration of the practice of the treating instances.(6 month)
  • Neurological outcome depending of the beginning of MIH(6 month)
  • Surviving after hospitalization(6 Month)

Study Sites (1)

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