Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329563
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : April 17, 2017
Medic One Foundation
Information provided by (Responsible Party):
Francis Kim, University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Arrest Drug: Up to 2 liter infusion of cold 4 degree C normal saline Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Study Start Date : November 2004
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cold fluid Drug: 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.
No Intervention: control, standard of care

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00329563

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

Responsible Party: Francis Kim, Associate Professor, Medicine, Division of Cardiology, University of Washington Identifier: NCT00329563     History of Changes
Other Study ID Numbers: 25186
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Keywords provided by Francis Kim, University of Washington:
Cardiac Arrest

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