Clinical trial NCT01472458: Premature Termination of Resuscitation in Survivors of Cardiac Arrest
Official title: Premature Termination of Resuscitation in Survivors of Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
Hypothermia
Post Cardiac Arrest Care
Survivors of cardiac arrest
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-11-16
Enrollment: 905
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on using innovative knowledge translation strategies to improve appropriate neuroprognostication for survivors of cardiac arrest and prevent premature termination of life sustaining therapies. This is important because any early gains achieved during resuscitation will be nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate prognostic information. An effective translation strategy for neuroprognostication will result in improved physician adherence to evidence-based medicine and an increase in the proportion of patients surviving to achieve a good neurological outcome following cardiac arrest.

Detailed description: A stepped wedge cluster randomized trial design will be employed in order to properly evaluate the impact of this intervention. Each of the 18 participating hospitals will be randomized one of the four wedges according to a random schedule; each wedge will consist of 4 to 5 hospitals. With this design, the implementation of the intervention will be rolled out sequentially to the participating hospitals over a 5 month period for each wedge. All hospitals will have received the intervention by the end of the study.

Note that the study design fields provided by ClinicalTrials.gov do not allow for describing this type of study design; therefore, the investigators have listed the study as a single arm. In reality, this study will have 4 wedges, each containing randomized clusters of 4-5 hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients =/\> 18 years of age
* Non-traumatic out of hospital cardiac arrest
* Sustained return of spontaneous circulation (palpable pulse for \> 20 minutes)
* Comatose (i.e. without full neurological recovery; non-responsive to verbal commands)
* Surviving to at least 6 hours after emergency department arrival

Exclusion Criteria:

* Patients who die within 6 hours of emergency department arrival

Primary outcomes:
measure: Effective knowledge strategy
timeFrame: Two years
Secondary outcomes:
measure: Qualitative Aim
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Damon C Scales, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scales DC, Golan E, Pinto R, Brooks SC, Chapman M, Dale CM, Jichici D, Rubenfeld GD, Morrison LJ; Strategies for Post-Arrest Resuscitation Care Network. Improving Appropriate Neurologic Prognostication after Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1083-1091. doi: 10.1164/rccm.201602-0397OC.