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OpenTrials
Completed

NCT Number: NCT01472458

Premature Termination of Resuscitation in Survivors of Cardiac Arrest

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality improvement

Behavioral

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.

Primary outcomes

  1. Effective knowledge strategy

    Time frame: Two years

    Our 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 outcomes

  1. Qualitative Aim

    Time frame: Two years

    To understand reasons for premature termination of life sustaining therapy and barriers to evidence based neurological prognostication in survivors of cardiac arrest.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada

Registry information

Acronym: PremaTOR

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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