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

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00843297
First received: February 12, 2009
Last updated: February 1, 2010
Last verified: January 2010
  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 efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Time to reach the target temperature [ Time Frame: Twenty-four hours ] [ Designated as safety issue: Yes ]
  • NSE as a parameter for cerebral damage [ Time Frame: Seventy-two hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neurologic outcome [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • Periprocedural complications [ Time Frame: Seventy-two hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: February 12, 2009
Last Updated: February 1, 2010
Health Authority: Germany: Ministry of Health

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

ClinicalTrials.gov processed this record on August 21, 2014