Trial record 4 of 9 for:    Open Studies | adoption

Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors

This study is currently recruiting participants.
Verified August 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01528475
First received: October 31, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.


Condition Intervention
Out of Hospital Cardiac Arrest
Behavioral: Pre-hospital cooling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-hospital Therapeutic Hypothermia in Cardiac Arrest Survivors: the ICE-PACS Trial

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Success of in-hospital cooling [ Time Frame: within 6 hours of emergency department arrival ] [ Designated as safety issue: No ]
    The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.


Secondary Outcome Measures:
  • Mortality at hospital discharge [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
    Proportion of deaths at hospital discharge

  • Mortality during transport [ Time Frame: During transport to hospital ] [ Designated as safety issue: Yes ]
    Proportion of patients that die after randomization and during transport to hospital.

  • Mortality during 6 hours [ Time Frame: Within 6 hours of emergency department arrival ] [ Designated as safety issue: Yes ]
    Proportion of patients that die within 6 hours of emergency department arrival

  • Cooling ever in hospital [ Time Frame: within 24 hours of emergency department arrival ] [ Designated as safety issue: No ]
    Proportion of patients for whom in-hospital therapeutic hypothermia is initiated or continued within 24 hours of emergency department arrival

  • Median Modified Rankin score at hospital discharge [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
    The median modified Rankin score at hospital discharge

  • Good neurological outcome [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
    The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge.

  • Time of transport to hospital [ Time Frame: During transport to hospital ] [ Designated as safety issue: Yes ]
    Mean time (minutes) from arrival of paramedics on the scene to arrival and transport of patient to emergency department.


Estimated Enrollment: 900
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pre-hospital cooling
Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs, initiation of an intravenous infusion of cold saline, and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.
Behavioral: Pre-hospital cooling
Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs on the neck, groin, and axillae; midazolam to prevent shivering; initiation of an intravenous infusion of cold saline; and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.
No Intervention: Usual pre-hospital care
Patients in this arm will receive usual post-resuscitation care by paramedics. Usual post-resuscitation care does not include initiation of cooling in the pre-hospital setting.

Detailed Description:

This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system. This study builds on our previous work using large hospital networks hospitals to improve the delivery of evidence-based practice.

The primary research question is as follows: Does pre-hospital initiation of therapeutic hypothermia by EMS providers increase the proportion of comatose out of hospital cardiac arrest patients with return of spontaneous circulation (ROSC) that are successfully cooled to a target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival, compared to usual post-resuscitation care provided in the field? The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pulseless OHCA in the study communities (any rhythm, initial rhythm will be recorded)
  • Age equal to or greater than 18 years
  • Defibrillation and/or chest compressions by EMS providers (including fire fighters)
  • Return of spontaneous circulation (ROSC) sustained for greater than or equal to 5 minutes
  • Patient is unresponsive to verbal stimulus using AVPU (Alert, Voice, Pain, Unresponsive) scale
  • Patient is endotracheally intubated
  • SBP equal to or greater than 100 mm Hg (even if needing dopamine)

Exclusion Criteria:

  • Trauma (including burns) associated with cardiac arrest
  • Sepsis or serious infection suspected as cause of cardiac arrest
  • Clinical evidence of active severe bleeding
  • Suspected hypothermic cardiac arrest
  • Known coagulopathy (medical history or medications; ASA and clopidogrel are permitted)
  • Any verbal or written do-not-resuscitate (DNR)
  • Obviously pregnant
  • Known Prisoner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528475

Contacts
Contact: Damon Scales, MD PhD 416-480-6100 ext 83734 damon.scales@sunnybrook.ca
Contact: Toula Gonedalles, BSc. 416-864-6060 ext 7872 gonedallese@smh.ca

Locations
Canada, Ontario
Peel Emergency Medical Services Recruiting
Mississauga, Ontario, Canada
Halton Emergency Medical Services Recruiting
Oakville, Ontario, Canada
Toronto Emergency Medical Services Recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Damon Scales, MD Sunnybrook Hospital
Study Chair: Laurie Morrison, M.D. St. Michael's Hospital, Toronto
Study Chair: Steven Brooks, M.D. Clinical Scientist
Study Chair: Rick Verbeek, MD Sunnybrook Centre for Prehospital Medicine
Study Chair: Sheldon Cheskes, MD Sunnybrook Centre for Prehospital Medicine
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01528475     History of Changes
Other Study ID Numbers: ICE PACS
Study First Received: October 31, 2011
Last Updated: August 26, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Therapeutic Hypothermia
Cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014