This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

This study has been completed.
Medic One Foundation
Information provided by (Responsible Party):
Francis Kim, University of Washington Identifier:
First received: May 22, 2006
Last updated: April 13, 2017
Last verified: April 2017
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 Drug: Up to 2 liter infusion of cold 4 degree C normal saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Resource links provided by NLM:

Further study details as provided by Francis Kim, 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
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00329563

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

Responsible Party: Francis Kim, Associate Professor, Medicine, Division of Cardiology, University of Washington Identifier: NCT00329563     History of Changes
Other Study ID Numbers: 25186
Study First Received: May 22, 2006
Last Updated: April 13, 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 processed this record on August 18, 2017