Therapeutic Hypothermia After the Return of Spontaneous Circulation - Full Text View

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:

MedlinePlus related topics: Cardiac Arrest Hypothermia

U.S. FDA Resources

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.

Estimated Enrollment:	400
Study Start Date:	March 2013
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (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

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

Contacts

Contact: Svetlana Bagdasarov, MPH

559-499-6440

sbagdasarov@fresno.ucsf.edu

Locations

United States, California
Community Regional Medical Center	Recruiting
Fresno, California, United States, 93701
Contact: Brandy Snowden, MPH 559-499-6440 bsnowden@fresno.ucsf.edu
Principal Investigator: Lori Weichenthal, MD
Sub-Investigator: Megann Young, MD
Sub-Investigator: Jim Andrews, MD
Sub-Investigator: Elisa Avik, MD

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Lori Weichenthal, MD

University of California San Francisco, Fresno

More Information

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.

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. 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.

Zeiner A, Holzer M, Sterz F, Behringer W, Schörkhuber W, Müllner 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.

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.

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.

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:	May 15, 2013
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 June 17, 2013