Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)

• Conditions: Hypothermia; Cardiac Arrest

• Registration Number: NCT01083069
• Lead Sponsor: University of Leipzig

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).

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-03-08
• Last Update Submitted: 2010-03-08
• Study First Posted: 2010-03-09
• Last Update Posted: 2010-03-09
• Primary Completion: 2010-12
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• survived cardiac arrest
• voluntary consent

Exclusion Criteria

• no voluntary consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological outcome after 6 month after MIH, Quality of life-survey	6 Month	Neurological outcome after 6 month after MIH measured by questionnaire.

Secondary Outcome Measures

Name	Time	Method
Managing daily activities	6 Month	Managing daily activities after 6 month after tMIH measured with a questionnaire.
Neurological Outcome in consideration of the practice of the treating instances.	6 month	Neurological outcome in consideration of the practice of the treating instances after restoration of spontanous circulation measured with a questionnaire.
Neurological outcome depending of the beginning of MIH	6 month	Neurological outcome depending of the beginning of MIH
Surviving after hospitalization	6 Month	Surviving after hospitalization after MIH

Trial Locations

Locations (1)

University of Leipzig, Heart Center, Cardiology; 🇩🇪 Leipzig, Germany