Therapeutic Hypothermia After the Return of Spontaneous Circulation

NCT01617291 | Terminated DMC

• 1 other identifier: 2012051
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Pre-hospital hypothermia; Induced therapeutic hypothermia; Cardiac arrest

Outcome Measures

Primary Outcomes (1)

• 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

  followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated

Secondary Outcomes (1)

• Regular treatment without induced therapeutic hypothermia

  followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated

Study Arms (2)

Induced Hypothermia

EXPERIMENTAL

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

Regular Care

NO INTERVENTION

Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia

Interventions

Induced therapeutic hypothermia OTHER

induced therapeutic hypothermia

Also known as: Medical Arrest, Cardiac Arrest, Return of spontaneous circulation, ROSC

Induced Hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient transported by CCEMS with ROSC after a medical Cardiac Arrest to hospitals that can continue ITH

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93701, United States

Location

Related Publications (9)

• 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.

  PMID: 17767436 BACKGROUND

• 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.

  PMID: 17583414 BACKGROUND

• 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.

  PMID: 16893352 BACKGROUND

• 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.

  PMID: 10625721 BACKGROUND

• 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.

  PMID: 11856794 BACKGROUND

• 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.

  PMID: 1404770 BACKGROUND

• 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.

  PMID: 20359771 BACKGROUND

• 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.

  PMID: 20679551 BACKGROUND

• 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.

  PMID: 20850254 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced; Heart Arrest, Induced; Return of Spontaneous Circulation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Lori Weichenthal, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Residency Director, Wilderness Medicine Director

Study Record Dates

• First Submitted: May 27, 2012
• First Posted: June 12, 2012
• Study Start: March 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (1)