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OpenTrials
Completed

NCT Number: NCT00329563

Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Up to 2 liter infusion of cold 4 degree C normal saline

Drug

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 outcomes

  1. Temperature difference between first field temperature and hospital arrival temperature

    Time frame: less than 60 minutes

Secondary outcomes

  1. Survival to discharge from hospital

    Time frame: Between 2 -30 days

  2. Awakening in the hospital

    Time frame: between 2-30 days

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Medic One Foundation

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
May 24, 2006
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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