Therapeutic Hypothermia After the Return of Spontaneous Circulation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study|
- Induced therapeutic hypothermia in the pre-hospital setting improves outcomes [ Time Frame: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated ] [ Designated as safety issue: No ]Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge
- Regular treatment without induced therapeutic hypothermia [ Time Frame: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated ] [ Designated as safety issue: No ]Patients will be treated under standing paramedic protocols without the induction of hypothermia. To determine if there is a difference in these outcomes in patients with prolonged transport to the hospital (> 20 minutes) versus those with shorter transport times.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: 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
Other: Induced therapeutic hypothermia
induced therapeutic hypothermia
No Intervention: Regular Care
Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia
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.
|Contact: Svetlana Bagdasarov, MPHemail@example.com|
|United States, California|
|Community Regional Medical Center||Recruiting|
|Fresno, California, United States, 93701|
|Contact: Brandy Snowden, MPH 559-499-6440 firstname.lastname@example.org|
|Principal Investigator: Lori Weichenthal, MD|
|Sub-Investigator: Megann Young, MD|
|Sub-Investigator: Jim Andrews, MD|
|Sub-Investigator: Elisa Avik, MD|
|Principal Investigator:||Lori Weichenthal, MD||University of California San Francisco, Fresno|