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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of the Use of Mild Hypothermia in Out-of-hospital Cardiac Arrest Using a Rapid Infusion of 2 Liters of Cold Normal Saline

Conditions
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Out-of-hospital Cardiac Arrest

Intervention / Treatment
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* Other: Rapid infusion of 2 liters of 4oC normal saline
* Drug: Rapid infusion of cold normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control treatment<br> | Other: Rapid infusion of 2 liters of 4oC normal saline<br>* Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.<br>* Other names: Rapid infusion of cold normal saline;Drug: Rapid infusion of cold normal saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Alive at Hospital Discharge |  | at hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic Status at Discharge-full Recovery |  | at time of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild hypothermia, cardiac arrest