Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

NCT ID: NCT00329563

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cold fluid

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

control, standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medic One Foundation

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Francis Kim

Associate Professor, Medicine, Division of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francis Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Other Identifiers

25186

Identifier Type: -

Identifier Source: org_study_id