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Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

NCT00329563 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2017-04-17

No results posted yet for this study

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.

Conditions

  • Cardiac Arrest

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Francis Kim, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2006-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00329563 on ClinicalTrials.gov