Therapeutic Hypothermia After the Return of Spontaneous Circulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.

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Detailed Description

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Induction of therapeutic hypothermia after return of spontaneous circulation (ROSC) in medical cardiac arrest is increasingly becoming the standard of care in the hospital setting. Several studies, including two sentinel research papers in the New England Journal of Medicine, show improved neurologic outcome with induced therapeutic hypothermia (ITH). 4, 5 This research led to a class IIa recommendation by the American Heart Association for ITH after ROSC in V-Fib arrest and a class IIb recommendation after ROSC in all other classes of medial cardiac arrest.6

The role of ITH in the pre-hospital setting is less clear. Studies currently exist that both show a benefit and fail to support improved outcomes.7-9 It has been suggested that the short transport times in most urban EMS systems might be part of the reason that some studies have failed to find benefit of ITH in the pre-hospital setting.

This is a prospective, randomized controlled trial involving all patients transported by CCEMS who have ROSC after a medical cardiac arrest and who are transported to a hospital that can continue ITH for 24 hours. All comatose patients who meet inclusion criteria will be randomized to either ITH in addition to continued treatment under standing protocols or regular care without ITH. Assignment to the two treatment arms will be done using the EMS number which is generated when the ambulance is dispatched to a call. Even numbered patients will have continued standard therapy while odd numbered patients will receive ITH.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Induced Hypothermia

Induced hypothermia after the return of spontaneous circulation by the application of ice packs to the axilla and groin with cold IV fluids

Group Type EXPERIMENTAL

Induced therapeutic hypothermia

Intervention Type OTHER

induced therapeutic hypothermia

Regular Care

Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Induced therapeutic hypothermia

induced therapeutic hypothermia

Intervention Type OTHER

Other Intervention Names

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Medical Arrest Cardiac Arrest Return of spontaneous circulation ROSC

Eligibility Criteria

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Inclusion Criteria

* All patient transported by CCEMS with ROSC after a medical Cardiac Arrest to hospitals that can continue ITH

Exclusion Criteria

* Less than 18
* Cardiac arrest due to trauma or hemorrhage
* Pregnant women
* patients whom are already hypothermic
* transported to a hospital that can not maintain hypothermia for 24 hours

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No