Therapeutic Hypothermia After the Return of Spontaneous Circulation
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|ClinicalTrials.gov Identifier: NCT01617291|
Recruitment Status : Terminated (A similar study was recently published with definitive results.)
First Posted : June 12, 2012
Last Update Posted : February 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Other: Induced therapeutic hypothermia||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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
- 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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617291
|United States, California|
|Community Regional Medical Center|
|Fresno, California, United States, 93701|
|Principal Investigator:||Lori Weichenthal, MD||University of California, San Francisco Fresno|