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

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ClinicalTrials.gov Identifier: NCT01528475
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Out of Hospital Cardiac Arrest Behavioral: Pre-hospital cooling Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : July 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Success of in-hospital cooling [ Time Frame: within 6 hours of emergency department arrival ]
    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 :
  1. Mortality at hospital discharge [ Time Frame: Hospital discharge ]
    Proportion of deaths at hospital discharge

  2. Mortality during transport [ Time Frame: During transport to hospital ]
    Proportion of patients that die after randomization and during transport to hospital.

  3. Mortality during 6 hours [ Time Frame: Within 6 hours of emergency department arrival ]
    Proportion of patients that die within 6 hours of emergency department arrival

  4. Cooling ever in hospital [ Time Frame: within 24 hours of emergency department arrival ]
    Proportion of patients for whom in-hospital therapeutic hypothermia is initiated or continued within 24 hours of emergency department arrival

  5. Median Modified Rankin score at hospital discharge [ Time Frame: hospital discharge ]
    The median modified Rankin score at hospital discharge

  6. Good neurological outcome [ Time Frame: hospital discharge ]
    The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge.

  7. Time of transport to hospital [ Time Frame: During transport to hospital ]
    Mean time (minutes) from arrival of paramedics on the scene to arrival and transport of patient to emergency department.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528475


Locations
Canada, Ontario
Peel Emergency Medical Services
Mississauga, Ontario, Canada
Halton Emergency Medical Services
Oakville, Ontario, Canada
Toronto Emergency Medical Services
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01528475     History of Changes
Other Study ID Numbers: ICE PACS
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

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