Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest

Phase 2

Completed

• Conditions: Out-of-hospital Cardiac Arrest
• Interventions: Other: Rapid infusion of 2 liters of 4oC normal saline; Drug: Rapid infusion of cold normal saline

• Registration Number: NCT00391469
• Lead Sponsor: University of Washington

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 Timeline

• Study First Submitted: 2006-10-20
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-24
• Study Start: 2007-12
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2014-11
• Results First Submitted: 2014-11-23
• Results First Submitted QC: 2014-11-23
• Last Update Submitted: 2014-11-23
• Results First Posted: 2014-12-02
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1359

Inclusion Criteria

• successful resuscitation from out-of-hospital cardiac arrest by paramedics, defined by having a palpable pulse

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Exclusion Criteria

• traumatic cause for cardiac arrest

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control treatment	Rapid infusion of cold normal saline	-
control treatment	Rapid infusion of 2 liters of 4oC normal saline	-

Primary Outcome Measures

Name	Time	Method
Number Alive at Hospital Discharge	at hospital discharge

Secondary Outcome Measures

Name	Time	Method
Neurologic Status at Discharge-full Recovery	at time of discharge

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States