Study of the Use of Mild Hypothermia in Out-of-hospital Cardiac Arrest Using a Rapid Infusion of 2 Liters of Cold Normal Saline
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 1,359
- Locations
- 1
- Primary Endpoint
- Number Alive at Hospital Discharge
Study Overview
Brief Summary
The overall goal of this study is to determine whether initiating hypothermia in cardiac arrest patients as soon as possible in the field results in a greater proportion of patients who survive to hospital discharge compared to standard prehospital/field care.
Detailed Description
In this study we will randomize 1,200 cardiac arrest patients who have 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 objective of this study will be to determine whether induction of mild hypothermia using an infusion of cold normal saline will improve the proportion of patients who survive and are discharged awake from the hospital.
Hypothesis
In cardiac arrest patients who achieve ROSC in the field, initiation of hypothermia by infusion of cold normal saline will result in a greater proportion of cardiac arrest patients discharged awake from the hospital compared to standard care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •successful resuscitation from out-of-hospital cardiac arrest by paramedics, defined by having a palpable pulse
Exclusion Criteria
- •traumatic cause for cardiac arrest
Arms & Interventions
control treatment
Intervention: Rapid infusion of 2 liters of 4oC normal saline (Other)
control treatment
Intervention: Rapid infusion of cold normal saline (Drug)
Outcomes
Primary Outcomes
Number Alive at Hospital Discharge
Time Frame: at hospital discharge
Secondary Outcomes
- Neurologic Status at Discharge-full Recovery(at time of discharge)
Investigators
Francis Kim
Study Principal Investigator
University of Washington