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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 because the information has not been verified recently.
Verified January 2010 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT01083069
First received: February 25, 2010
Last updated: March 8, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition
Cardiac Arrest
Hypothermia

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Neurological outcome after 6 month after MIH measured by questionnaire.


Secondary Outcome Measures:
  • 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.


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)
Groups/Cohorts
COOL
Patients after therapy with mild hypothermia
UnCool
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients after restoration of spontaneous circulation

Criteria

Inclusion Criteria:

  • survived cardiac arrest
  • voluntary consent

Exclusion Criteria:

  • no voluntary consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083069

Contacts
Contact: Undine Pittl, MD 0049-341-8651427 undine.pittl@gmail.com
Contact: Holger Thiele, Associate Professor 0049-341-8651427 thielh@med.uni-leipzig.de

Locations
Germany
University of Leipzig, Heart Center, Cardiology Recruiting
Leipzig, Germany
Contact: Undine Pittl, MD     0049-341-8651427     undine.pittl@gmail.com    
Contact: Holger Thiele, Associate Professor     0049-341-8651427     thielh@med.uni-leipzig.de    
Principal Investigator: Holger Thiele, Associate Professor            
Sub-Investigator: Undine Pittl, MD            
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Holger Thiele, Associate Professor Study Chair
Study Director: Undine Pittl, MD Study Sub-invesigator
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013