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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
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac Arrest, Hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 22, 2006
    Last Updated
    April 13, 2017
    Sponsor
    University of Washington
    Collaborators
    Medic One Foundation
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    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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