Therapeutic Hypothermia After the Return of Spontaneous Circulation
Primary Purpose
Cardiac Arrest
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Induced therapeutic hypothermia
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring Pre-hospital hypothermia, Induced therapeutic hypothermia, Cardiac arrest
Eligibility Criteria
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
Sites / Locations
- Community Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Induced Hypothermia
Regular Care
Arm 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 of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia
Outcomes
Primary Outcome Measures
Induced therapeutic hypothermia in the pre-hospital setting improves outcomes
Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge
Secondary Outcome Measures
Regular treatment without induced therapeutic hypothermia
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.
Full Information
NCT ID
NCT01617291
First Posted
May 27, 2012
Last Updated
February 12, 2014
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01617291
Brief Title
Therapeutic Hypothermia After the Return of Spontaneous Circulation
Official Title
Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
A similar study was recently published with definitive results.
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Pre-hospital hypothermia, Induced therapeutic hypothermia, Cardiac arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induced Hypothermia
Arm Type
Experimental
Arm Description
Induced hypothermia after the return of spontaneous circulation by the application of ice packs to the axilla and groin with cold IV fluids
Arm Title
Regular Care
Arm Type
No Intervention
Arm Description
Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia
Intervention Type
Other
Intervention Name(s)
Induced therapeutic hypothermia
Other Intervention Name(s)
Medical Arrest, Cardiac Arrest, Return of spontaneous circulation, ROSC
Intervention Description
induced therapeutic hypothermia
Primary Outcome Measure Information:
Title
Induced therapeutic hypothermia in the pre-hospital setting improves outcomes
Description
Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge
Time Frame
followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
Secondary Outcome Measure Information:
Title
Regular treatment without induced therapeutic hypothermia
Description
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.
Time Frame
followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Weichenthal, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17767436
Citation
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.
Results Reference
background
PubMed Identifier
17583414
Citation
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.
Results Reference
background
PubMed Identifier
16893352
Citation
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.
Results Reference
background
PubMed Identifier
10625721
Citation
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.
Results Reference
background
PubMed Identifier
11856794
Citation
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.
Results Reference
background
PubMed Identifier
1404770
Citation
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.
Results Reference
background
PubMed Identifier
20359771
Citation
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.
Results Reference
background
PubMed Identifier
20679551
Citation
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.
Results Reference
background
PubMed Identifier
20850254
Citation
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.
Results Reference
background
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Therapeutic Hypothermia After the Return of Spontaneous Circulation
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