Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation|
- Neurological outcome after 6 month after MIH, Quality of life-survey [ Time Frame: 6 Month ] [ Designated as safety issue: No ]Neurological outcome after 6 month after MIH measured by questionnaire.
- Managing daily activities [ Time Frame: 6 Month ] [ Designated as safety issue: No ]Managing daily activities after 6 month after tMIH measured with a questionnaire.
- Surviving after hospitalization [ Time Frame: 6 Month ] [ Designated as safety issue: No ]Surviving after hospitalization after MIH
- Neurological outcome depending of the beginning of MIH [ Time Frame: 6 month ] [ Designated as safety issue: No ]Neurological outcome depending of the beginning of MIH
- Neurological Outcome in consideration of the practice of the treating instances. [ Time Frame: 6 month ] [ Designated as safety issue: No ]Neurological outcome in consideration of the practice of the treating instances after restoration of spontanous circulation measured with a questionnaire.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Patients after therapy with mild hypothermia
Patients without therapy with mild hypothermia due to non-operational cooling-devices
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083069
|Contact: Undine Pittl, MDfirstname.lastname@example.org|
|Contact: Holger Thiele, Associate Professoremail@example.com|
|University of Leipzig, Heart Center, Cardiology||Recruiting|
|Contact: Undine Pittl, MD 0049-341-8651427 firstname.lastname@example.org|
|Contact: Holger Thiele, Associate Professor 0049-341-8651427 email@example.com|
|Principal Investigator: Holger Thiele, Associate Professor|
|Sub-Investigator: Undine Pittl, MD|
|Principal Investigator:||Holger Thiele, Associate Professor||Study Chair|
|Study Director:||Undine Pittl, MD||Study Sub-invesigator|