Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Cardiac Arrest Clinical Trial

— PremaTOR  

Official title:

Premature Termination of Resuscitation in Survivors of Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472458
• Other study ID #: SPARC - PremaTOR
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: February 3, 2017
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: February 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 905
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Behavioral:
• Quality 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective knowledge strategy	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.	Two years
Secondary	Qualitative Aim	To understand reasons for premature termination of life sustaining therapy and barriers to evidence based neurological prognostication in survivors of cardiac arrest.	Two years