Therapeutic Hypothermia After the Return of Spontaneous Circulation
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Hospital |
Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2014 |
Start Date: | March 2013 |
End Date: | December 2016 |
Contact: | Svetlana Bagdasarov, MPH |
Email: | sbagdasarov@fresno.ucsf.edu |
Phone: | 559-499-6440 |
Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study
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.
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.
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.
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.
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
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