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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01083069
• Other study ID #: Cool-Trial Follow up
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2010
• Last updated: March 8, 2010
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2010
• Source: University of Leipzig
• Contact: Undine Pittl, MD
• Phone: 0049-341-8651427
• Email: undine.pittl[@]gmail.com
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• survived cardiac arrest

• voluntary consent

Exclusion Criteria:

• no voluntary consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Locations

Country	Name	City	State
Germany	University of Leipzig, Heart Center, Cardiology	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological outcome after 6 month after MIH, Quality of life-survey	Neurological outcome after 6 month after MIH measured by questionnaire.	6 Month	No
Secondary	Managing daily activities	Managing daily activities after 6 month after tMIH measured with a questionnaire.	6 Month	No
Secondary	Surviving after hospitalization	Surviving after hospitalization after MIH	6 Month	No
Secondary	Neurological outcome depending of the beginning of MIH	Neurological outcome depending of the beginning of MIH	6 month	No
Secondary	Neurological Outcome in consideration of the practice of the treating instances.	Neurological outcome in consideration of the practice of the treating instances after restoration of spontanous circulation measured with a questionnaire.	6 month	No