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

NCT ID: NCT01083069

Last Updated: 2010-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cardiac Arrest Hypothermia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COOL

Patients after therapy with mild hypothermia

No interventions assigned to this group

UnCool

Patients without therapy with mild hypothermia due to non-operational cooling-devices

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* survived cardiac arrest
* voluntary consent

Exclusion Criteria

* no voluntary consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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University of Leipzig, Heart center

Principal Investigators

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Holger Thiele, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Study Chair

Undine Pittl, MD

Role: STUDY_DIRECTOR

Study Sub-invesigator

Locations

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University of Leipzig, Heart Center, Cardiology

Leipzig, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Undine Pittl, MD

Role: CONTACT

[email protected]
0049-341-8651427

Holger Thiele, Associate Professor

Role: CONTACT

[email protected]
0049-341-8651427

Facility Contacts

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Undine Pittl, MD

Role: primary

[email protected]
0049-341-8651427

Holger Thiele, Associate Professor

Role: backup

[email protected]
0049-341-8651427

Other Identifiers

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Cool-Trial Follow up

Identifier Type: -

Identifier Source: org_study_id

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