- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617291
Therapeutic Hypothermia After the Return of Spontaneous Circulation
Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Fresno, California, United States, 93701
- Community Regional Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
induced therapeutic hypothermia
Other Names:
|
No Intervention: Regular Care
Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lori Weichenthal, MD, University of California, San Francisco Fresno
Publications and helpful links
General Publications
- Finn JC, Bett JH, Shilton TR, Cunningham C, Thompson PL; National Heart Foundation of Australia Chest Pain Every Minute Counts Working Group. Patient delay in responding to symptoms of possible heart attack: can we reduce time to care? Med J Aust. 2007 Sep 3;187(5):293-8. doi: 10.5694/j.1326-5377.2007.tb01247.x.
- Fridman M, Barnes V, Whyman A, Currell A, Bernard S, Walker T, Smith KL. A model of survival following pre-hospital cardiac arrest based on the Victorian Ambulance Cardiac Arrest Register. Resuscitation. 2007 Nov;75(2):311-22. doi: 10.1016/j.resuscitation.2007.05.005. Epub 2007 Jun 20.
- Jennings PA, Cameron P, Walker T, Bernard S, Smith K. Out-of-hospital cardiac arrest in Victoria: rural and urban outcomes. Med J Aust. 2006 Aug 7;185(3):135-9. doi: 10.5694/j.1326-5377.2006.tb00498.x.
- Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
- Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
- Guidelines for cardiopulmonary resuscitation and emergency cardiac care. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Part IV. Special resuscitation situations. JAMA. 1992 Oct 28;268(16):2242-50. No abstract available.
- Hinchey PR, Myers JB, Lewis R, De Maio VJ, Reyer E, Licatese D, Zalkin J, Snyder G; Capital County Research Consortium. Improved out-of-hospital cardiac arrest survival after the sequential implementation of 2005 AHA guidelines for compressions, ventilations, and induced hypothermia: the Wake County experience. Ann Emerg Med. 2010 Oct;56(4):348-57. doi: 10.1016/j.annemergmed.2010.01.036. Epub 2010 Mar 31.
- Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns (RICH) Investigators. Induction of therapeutic hypothermia by paramedics after resuscitation from out-of-hospital ventricular fibrillation cardiac arrest: a randomized controlled trial. Circulation. 2010 Aug 17;122(7):737-42. doi: 10.1161/CIRCULATIONAHA.109.906859. Epub 2010 Aug 2.
- Cabanas JG, Brice JH, De Maio VJ, Myers B, Hinchey PR. Field-induced therapeutic hypothermia for neuroprotection after out-of hospital cardiac arrest: a systematic review of the literature. J Emerg Med. 2011 Apr;40(4):400-9. doi: 10.1016/j.jemermed.2010.07.002. Epub 2010 Sep 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012051
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Arrest
-
Italian Resuscitation CouncilUnknownOut-Of-Hospital Cardiac Arrest | In-hospital Cardiac ArrestItaly
-
Australian and New Zealand Intensive Care Research...Ambulance VictoriaNot yet recruitingOut of Hospital Cardiac Arrest
-
University Medical Centre MariborRecruiting
-
IRCCS Policlinico S. MatteoOslo University Hospital; University of the Basque Country (UPV/EHU); The Hospital...CompletedOut-Of-Hospital Cardiac ArrestItaly, Norway, Spain
-
Lithuanian University of Health SciencesEgle Vaitkaitiene; Dinas Vaitkaitis; Asta Krikscionaitiene; Ilona Kajokaite; Nerijus...CompletedOut-Of-Hospital Cardiac ArrestLithuania
-
Ceric SàrlAbbottTerminatedOut of Hospital Cardiac ArrestBelgium, France, Serbia
-
Prehospital Center, Region ZealandCompletedOut-Of-Hospital Cardiac Arrest
-
Karolinska InstitutetSwedish Heart Lung FoundationCompletedCardiac Arrest | Out of Hospital Cardiac ArrestSweden
-
Karolinska InstitutetVastra Gotaland Region; SOS Alarm Sverige AB; Everdrone AB; Aviation capacity resources... and other collaboratorsCompleted
-
Brno University HospitalTerminatedOut-Of-Hospital Cardiac ArrestCzechia
Clinical Trials on Induced therapeutic hypothermia
-
Lawson Health Research InstituteUniversity of Western Ontario, CanadaUnknownPulseless Electrical Activity | Asystole | Postcardiac ArrestCanada
-
Mid and South Essex NHS Foundation TrustCompletedCardiac ArrestUnited Kingdom
-
Australia and New Zealand Intensive Care SocietyCompletedTraumatic Brain InjuryAustralia, New Zealand
-
Centre Hospitalier Universitaire, AmiensCompletedPrediction by the Synek Score of Poor Neurological Outcome in Postanoxic Comatose Patients Treated With Induced HypothermiaFrance
-
Phoenix Children's HospitalNational Institutes of Health (NIH)TerminatedTraumatic Brain InjuryUnited States, Australia, Canada, New Zealand, South Africa, United Kingdom
-
WellStar Health SystemWithdrawnIschemic Stroke | HypothermiaUnited States
-
NICHD Neonatal Research NetworkNational Center for Research Resources (NCRR)CompletedHypoxia-Ischemia, Brain | Infant, NewbornUnited States
-
Danish Procalcitonin Study GroupLundbeck Foundation; TRYG FoundationTerminatedSeptic ShockNetherlands, Denmark, United States
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)CompletedCardiac ArrestUnited States, Canada, United Kingdom
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)CompletedCardiac ArrestUnited States, Canada