Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Up to 2 liter infusion of cold 4 degree C normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac Arrest, Hypothermia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cold fluid
control, standard of care
Arm Description
Outcomes
Primary Outcome Measures
Temperature difference between first field temperature and hospital arrival temperature
Secondary Outcome Measures
Survival to discharge from hospital
Awakening in the hospital
Full Information
NCT ID
NCT00329563
First Posted
May 22, 2006
Last Updated
April 13, 2017
Sponsor
University of Washington
Collaborators
Medic One Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00329563
Brief Title
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Official Title
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Medic One Foundation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac Arrest, Hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold fluid
Arm Type
Experimental
Arm Title
control, standard of care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Up to 2 liter infusion of cold 4 degree C normal saline
Intervention Description
Patients randomized to field cooling will receive up to 2 liters of 4oC normal saline. Control patients will receive standard of care following resuscitation.
Primary Outcome Measure Information:
Title
Temperature difference between first field temperature and hospital arrival temperature
Time Frame
less than 60 minutes
Secondary Outcome Measure Information:
Title
Survival to discharge from hospital
Time Frame
Between 2 -30 days
Title
Awakening in the hospital
Time Frame
between 2-30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Kim, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
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