Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

NCT00329563 | Completed Phase 1

• 1 other identifier: 25186
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest; Hypothermia

Outcome Measures

Primary Outcomes (1)

• Temperature difference between first field temperature and hospital arrival temperature

  less than 60 minutes

Secondary Outcomes (2)

• Survival to discharge from hospital

  Between 2 -30 days

• Awakening in the hospital

  between 2-30 days

Study Arms (2)

Cold fluid

EXPERIMENTAL

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

control, standard of care

NO INTERVENTION

Interventions

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.

Cold fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• age less than 18 traumatic cause of cardiac arrest

Sponsors & Collaborators

• University of Washington: lead
• Medic One Foundation: collaborator

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis Kim, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine, Division of Cardiology

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: November 1, 2004
• Study Completion: March 1, 2006
• Last Updated: April 17, 2017

Record last verified: 2017-04