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Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00329563
Enrollment
125
Registered
2006-05-24
Start date
2004-11-30
Completion date
2006-03-31
Last updated
2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest, Hypothermia

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.

Interventions

DRUGUp 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

Medic One Foundation
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Temperature difference between first field temperature and hospital arrival temperatureless than 60 minutes

Secondary

MeasureTime frame
Survival to discharge from hospitalBetween 2 -30 days
Awakening in the hospitalbetween 2-30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026