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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by University of Leipzig.
Recruitment status was:  Recruiting
Information provided by:
University of Leipzig Identifier:
First received: February 25, 2010
Last updated: March 8, 2010
Last verified: January 2010
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.

Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation

Resource links provided by NLM:

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Managing daily activities [ Time Frame: 6 Month ]
    Managing daily activities after 6 month after tMIH measured with a questionnaire.

  • Surviving after hospitalization [ Time Frame: 6 Month ]
    Surviving after hospitalization after MIH

  • Neurological outcome depending of the beginning of MIH [ Time Frame: 6 month ]
    Neurological outcome depending of the beginning of MIH

  • Neurological Outcome in consideration of the practice of the treating instances. [ Time Frame: 6 month ]
    Neurological outcome in consideration of the practice of the treating instances after restoration of spontanous circulation measured with a questionnaire.

Estimated Enrollment: 150
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

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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients after restoration of spontaneous circulation

Inclusion Criteria:

  • survived cardiac arrest
  • voluntary consent

Exclusion Criteria:

  • no voluntary consent
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Please refer to this study by its identifier: NCT01083069

University of Leipzig, Heart Center, Cardiology
Leipzig, Germany
Sponsors and Collaborators
University of Leipzig
Principal Investigator: Holger Thiele, Associate Professor Study Chair
Study Director: Undine Pittl, MD Study Sub-invesigator
  More Information

Responsible Party: Holger Thiele, Associate Professor Study Chair, University of Leipzig, Heart center Identifier: NCT01083069     History of Changes
Other Study ID Numbers: Cool-Trial Follow up 
Study First Received: February 25, 2010
Last Updated: March 8, 2010

Keywords provided by University of Leipzig:
Sudden cardiac arrest
neurological outcome

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms processed this record on February 20, 2017