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Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01472458
Acronym
PremaTOR
Enrollment
905
Registered
2011-11-16
Start date
2011-11-30
Completion date
2014-06-30
Last updated
2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

Cardiac arrest, Hypothermia, Post Cardiac Arrest Care, Survivors of cardiac arrest

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.

Interventions

BEHAVIORALQuality improvement

The primary intervention in this project will be a multi-faceted quality improvement plan targeting improved predictions of neurological outcome and survival after cardiac arrest.

Sponsors

Heart and Stroke Foundation of Canada
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effective knowledge strategyTwo yearsOur primary endpoint measures the uptake of appropriate neurological prognostication in survivors of cardiac arrest. We define appropriate neurological prognostication as the number of patients that have appropriate prognostic testing (as recommended by Advanced Life Support/ILCOR guidelines) performed before death but occurring at least 72 hours after the cardiac arrest; the denominator for this endpoint is the total number of patients admitted to hospital following cardiac arrest excluding deaths unrelated to predictions of poor neurological prognosis.

Secondary

MeasureTime frameDescription
Qualitative AimTwo yearsTo understand reasons for premature termination of life sustaining therapy and barriers to evidence based neurological prognostication in survivors of cardiac arrest.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026