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Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

This study has been completed.
Sponsor:
Collaborator:
Medic One Foundation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00329563
First received: May 22, 2006
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  Purpose

The overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. In this pilot study we will randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy. The primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.


Condition Intervention Phase
Cardiac Arrest
 Procedure: Up to 2 liter infusion of cold 4 degree C normal saline
Procedure: Induction of mild hypothermia
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Temperature difference between first field temperature and hospital arrival temperature [ Time Frame: less than 60 minutes ]

Secondary Outcome Measures:
  • Survival to discharge from hospital [ Time Frame: Between 2 -30 days ]
  • Awakening in the hospital [ Time Frame: between 2-30 days ]

Enrollment: 125
Study Start Date: November 2004
Study Completion Date: March 2006
Intervention Details:
    Procedure: Up to 2 liter infusion of cold 4 degree C normal saline
    Patients randomized to field cooling will receive up to 2 liters of 4oC normal saline. Control patients will receive standard of care following resuscitation.
    Procedure: Induction of mild hypothermia
    Patients randomized to field cooling will receive up to 2 liters of 4oC normal saline.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose IV access Intubated

Exclusion Criteria:

  • age less than 18 traumatic cause of cardiac arrest
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329563

Sponsors and Collaborators
University of Washington
Medic One Foundation
Investigators
Principal Investigator: Francis Kim, MD University of Washington
  More Information

No publications provided

Responsible Party: Francis Kim, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00329563     History of Changes
Other Study ID Numbers: 03-9863-B03
Study First Received: May 22, 2006
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Cardiac Arrest
Hypothermia

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

ClinicalTrials.gov processed this record on June 17, 2013