Therapeutic Hypothermia After the Return of Spontaneous Circulation

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Cardiac Arrest

Treatments: Other: Induced therapeutic hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT01617291

2012051

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Induced Hypothermia

Experimental group

Description:

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

Treatment:

Other: Induced therapeutic hypothermia

Regular Care

No Intervention group

Description:

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