Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

April 13, 2017 updated by: Francis Kim, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Temperature difference between first field temperature and hospital arrival temperature
Time Frame: less than 60 minutes
less than 60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival to discharge from hospital
Time Frame: Between 2 -30 days
Between 2 -30 days
Awakening in the hospital
Time Frame: between 2-30 days
between 2-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Medic One Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

May 22, 2006

First Submitted That Met QC Criteria

May 22, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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