Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Phase 1

Completed

• Conditions: Cardiac Arrest
• Interventions: Drug: Up to 2 liter infusion of cold 4 degree C normal saline

• Registration Number: NCT00329563
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study Completion: 2006-03
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose IV access Intubated

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Exclusion Criteria

• age less than 18 traumatic cause of cardiac arrest

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold fluid	Up to 2 liter infusion of cold 4 degree C normal saline	-

Primary Outcome Measures

Name	Time	Method
Temperature difference between first field temperature and hospital arrival temperature	less than 60 minutes

Secondary Outcome Measures

Name	Time	Method
Survival to discharge from hospital	Between 2 -30 days
Awakening in the hospital	between 2-30 days