Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329563
• Other study ID #: 25186
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 22, 2006
• Last updated: April 13, 2017
• Start date: November 2004
• Est. completion date: March 2006

Study information

• Verified date: April 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Medic One Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature difference between first field temperature and hospital arrival temperature		less than 60 minutes
Secondary	Survival to discharge from hospital		Between 2 -30 days
Secondary	Awakening in the hospital		between 2-30 days