Therapeutic Hypothermia After the Return of Spontaneous Circulation

This study has been terminated.
(A similar study was recently published with definitive results.)
Sponsor:
Information provided by (Responsible Party):
Lori Weichenthal, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01617291
First received: May 27, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Cardiac Arrest
Other: Induced therapeutic hypothermia

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 46
Study Start Date: March 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Medical Arrest
  • Cardiac Arrest
  • Return of spontaneous circulation
  • ROSC
  • 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617291

Locations
United States, California
Community Regional Medical Center
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Lori Weichenthal, MD University of California San Francisco, Fresno
  More Information

Publications:
Hinchey PR, Myers JB, Lewis R, De Maio VJ, Reyer E, Licatese D, Zalkin J, Snyder G. Improved out of hospital cardiac arrest survival after sequential implementation of 2005 AHA guidelines for compressions, ventilations, and induced hypothermia: The Wake County experience. Ann Emerg Med. 2010; 56: 348-357
Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper J, Kelly A, Silvester W. Induction of therapeutic hypothermia by paramedics after resuscitation from out of hospital ventricular fibrillation cardiac arrest: A randomized controlled trial. Circulation. 2010; 122: 737-742.

Responsible Party: Lori Weichenthal, Associate Residency Director, Wilderness Medicine Director, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01617291     History of Changes
Other Study ID Numbers: 2012051
Study First Received: May 27, 2012
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Pre-hospital hypothermia
Induced therapeutic hypothermia
Cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014