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COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest (COOL)

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ClinicalTrials.gov Identifier: NCT00843297
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
University of Leipzig

Brief 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 efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Hypothermia Device: Coolgard Device: ArcticSun Other: Conventional treatment Phase 4

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). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest
Study Start Date : April 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CG
Coolgard: invasive Cooling
Device: Coolgard
invasive Cooling via femoral ICY-catheter

Active Comparator: AS
ArcticSun: Surface-Cooling
Device: ArcticSun
Noninvasive surface-cooling by saline-cooled thermo-vest

Sham Comparator: UnCOOL
No Cooling-Therapy due to non-operational cooling-devices
Other: Conventional treatment
Intensive care-treatment without cooling




Primary Outcome Measures :
  1. Time to reach the target temperature [ Time Frame: Twenty-four hours ]
  2. NSE as a parameter for cerebral damage [ Time Frame: Seventy-two hours ]

Secondary Outcome Measures :
  1. Neurologic outcome [ Time Frame: Six months ]
  2. Survival [ Time Frame: Six months ]
  3. Periprocedural complications [ Time Frame: Seventy-two hours ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ROSC after SCA due to VF/VT or PEA/Asystolia
  • GCS 3

Exclusion Criteria:

  • Non-cardiac SCA
  • Pregnancy
  • Unstable Circulation instead of High-dose Inotropics
  • Life-expectancy reducing concomitant illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843297


Locations
Germany
University of Leipzig, Heart Center, Cardiology
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Holger Thiele, Associate Professor Study Chair
Study Director: Undine Pittl, MD Study Sub-Investigator

Publications:
Responsible Party: Holger Thiele, Assistant Professor, University of Leipzig, Heart Center
ClinicalTrials.gov Identifier: NCT00843297     History of Changes
Other Study ID Numbers: COOL-Trial
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2010

Keywords provided by University of Leipzig:
Sudden Cardiac Arrest
Hypothermia
Outcome, neurological
Coolgard
ArcticSun

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Death, Sudden
Death
Pathologic Processes