Clinical trial NCT01528475: Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out of Hospital Cardiac Arrest
Keywords: Therapeutic Hypothermia
Cardiac arrest
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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

Primary outcomes:
measure: Success of in-hospital cooling
timeFrame: within 6 hours of emergency department arrival
Secondary outcomes:
measure: Mortality at hospital discharge
timeFrame: Hospital discharge
measure: Mortality during transport
timeFrame: During transport to hospital
measure: Mortality during 6 hours
timeFrame: Within 6 hours of emergency department arrival
measure: Cooling ever in hospital
timeFrame: within 24 hours of emergency department arrival
measure: Median Modified Rankin score at hospital discharge
timeFrame: hospital discharge
measure: Good neurological outcome
timeFrame: hospital discharge
measure: Time of transport to hospital
timeFrame: During transport to hospital
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Peel Emergency Medical Services
state: Ontario
city: Oakville
country: Canada
facility: Halton Emergency Medical Services
state: Ontario
city: Toronto
country: Canada
facility: Toronto Emergency Medical Services
state: Ontario
Study officials:
affiliation: Sunnybrook Hospital
name: Damon Scales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Laurie Morrison, M.D.
role: STUDY_CHAIR
affiliation: Clinical Scientist
name: Steven Brooks, M.D.
role: STUDY_CHAIR
affiliation: Sunnybrook Centre for Prehospital Medicine
name: Rick Verbeek, MD
role: STUDY_CHAIR
affiliation: Sunnybrook Centre for Prehospital Medicine
name: Sheldon Cheskes, MD
role: STUDY_CHAIR
References: