Study of Survivors of Different Types of Cardiac Arrest and Their Neurological Recovery

January 9, 2014 updated by: Eyad AlThenayan, Lawson Health Research Institute

Neurological Outcomes After Cardiac Arrest in Pulseless Electrical Activity in Comparison to Asystole. Are All Non-shockable Rhythms the Same?

After successful resuscitation from certain types of cardiac arrest, total body cooling is now a well established treatment that improves the chances of the brain recovering. This however, has only been definitively proven after a certain type of cardiac arrest that is "ventricular fibrillation / ventricular tachycardia". The purpose of this study is to explore if total body cooling is beneficial for patients recovering from another type of cardiac arrest that is "pulseless electrical activity".

HYPOTHESIS:

Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison to asystole.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

STUDY RATIONALE AND BACKGROUND INFORMATION:

After successful resuscitation from cardiac arrest the body experiences a period of global reperfusion. During this period, patients may show signs of myocardial stunning, lactic acidosis, neurological injury and reperfusion syndrome. This constellation of findings constitutes what is known as post-cardiac arrest syndrome. The brain appears to be one of the most vulnerable organs to injury during this reperfusion phase and varying degrees of cognitive impairment may be the end result. Inducing mild therapeutic hypothermia has been shown to be protective for the brain in this setting and has been demonstrated to improve neurological recovery. The evidence for this however, is only conclusive in cases where the arrest is in a shockable rhythm i.e. pulseless ventricular tachycardia and ventricular fibrillation.

In 2002, two randomized controlled trials were published showing an improvement in neurological outcomes in patients treated with mild therapeutic hypothermia post resuscitation from shockable cardiac arrest. Therapeutic hypothermia has since been widely adopted by most authorities as part of the comprehensive treatment bundle for post cardiac arrest syndrome. Whether there is any benefit for patients arrested in non-shockable rhythms however, is a matter of controversy. Some have reported improved mortality and better neurological outcomes with therapeutic hypothermia in this patient population. Others have reported no benefit or even a trend towards harm. And although the matter remains controversial, the recommendation still stands for therapeutic hypothermia to be offered for all comatose survivors of cardiac arrest whatever the arrest rhythm.

Most previous reports have examined the differences between shockable and non-shockable rhythms in terms of neurological outcome and mortality rates after therapeutic hypothermia. To our knowledge, no study has examined the differences in outcome between the two types of non-shockable rhythms, that is pulseless electrical activity (PEA) and asystole. We hypothesize that during PEA arrests, patients may retain some degree of cerebral perfusion and hence have better neurological outcomes post-resuscitation. That is in contrast to asystole where patients are likely to have no cerebral perfusion. In this study we attempt to detect any possible differences in neurological recovery (as indicated by the Cerebral Performance Category scale on hospital discharge) after therapeutic hypothermia, between patients arrested in PEA arrest and those arrested in asystole.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University Hospital, London Health Sciences Centre, University of Western Ontario
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ahmed F Hegazy, MD, FRCPC
      • London, Ontario, Canada, N6A 5W9
        • Victoria Hospital, London Health Sciences Centre, University of Western Ontario
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ahmed F Hegazy, MD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the intensive care unit (ICU) with a diagnosis of postcardiac arrest between Jan 2008 and Dec 2012 will be examined.

Description

Inclusion Criteria:

  • Admission to adult ICU (age ≥18 years) at London Health Sciences Centre
  • Primary reason for ICU admission: postcardiac arrest
  • Both in-hospital and out-of-hospital cardiac arrest will be included
  • ICU admission between Jan 2008 and Dec 2012.

Exclusion Criteria:

- ICU admissions primarily for reasons other than cardiac arrest.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Shockable arrest
Initial arrest rhythm shockable. This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF).
Other: No treatment
No therapeutic hypothermia was induced.
Other Names:
  • No therapeutic hypothermia.
  • Control.
Other: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Other Names:
  • Hypothermia
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Cooling
  • Targeted temperature management
Pulseless electrical activity
Initial arrest rhythm is pulseless electrical activity.
Other: No treatment
No therapeutic hypothermia was induced.
Other Names:
  • No therapeutic hypothermia.
  • Control.
Other: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Other Names:
  • Hypothermia
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Cooling
  • Targeted temperature management
Asystole
Initial arrest rhythm is asystole.
Other: No treatment
No therapeutic hypothermia was induced.
Other Names:
  • No therapeutic hypothermia.
  • Control.
Other: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Other Names:
  • Hypothermia
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Cooling
  • Targeted temperature management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral performance category score on hospital discharge
Time Frame: Upon discharge from hospital, assessed up to 36 months postcardiac arrest

Neurological outcome on discharge from hospital as defined by the cerebral performance category (CPC) scale. The CPC scale is a 5 point scale. The outcome measure will be dichotomized into good or bad. Good outcome will be equivalent to CPC scores of 1 & 2 (where the patient is independent), and bad outcome will be equivalent to CPC scores of 3, 4 & 5 (where the patient is either dependent or dead).

CPC Scale:

  1. Functioning normally and independent, possibly with a minor disability.
  2. Moderately disabled, still independent.
  3. Conscious but with a severe disability, dependent.
  4. Unconscious (comatose or in a persistent vegetative state).
  5. Brain dead or dead by traditional criteria.
Upon discharge from hospital, assessed up to 36 months postcardiac arrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay postcardiac arrest
Time Frame: Days spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
Hospital length of stay (LOS) post-cardiac arrest will be calculated from the day of the cardiac arrest to the day of hospital discharge. If prior to the arrest the patient was an inpatient, we will only count the days from the arrest to discharge. Days spent in hospital prior to the arrest will not be included.
Days spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
Intensive care unit length of stay postcardiac arrest
Time Frame: Days spent in the intensive care unit after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
The length of stay (LOS) in the intensive care unit (ICU) in days, after successful resuscitation from cardiac arrest.
Days spent in the intensive care unit after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
Neurological status after hospital discharge
Time Frame: Assessed up to 12 months from hospital discharge
Neurological status as documented on the patient's first outpatient clinic visit, assessed up to 12 months from hospital discharge. This will be analyzed as a secondary outcome only if enough data is generated on chart review.
Assessed up to 12 months from hospital discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to obeying commands
Time Frame: Assessed up to 21 days postcardiac arrest
Total time in days from the cardiac arrest until the patient is able to obey commands, as documented in the patient's chart.
Assessed up to 21 days postcardiac arrest
Documented negative neurological prognosticators
Time Frame: Upon withdrawal of life support, assessed up to 3 months postcardiac arrest

For patient's in which the reason for withdrawal of life support is poor neurological outcome, the number of negative neurological prognosticators recorded in the chart will be examined.

Examples of negative prognosticators include: negative somatosensory evoked potentials on post arrest day 3, post arrest status epilepticus, absent brain stem reflexes beyond post arrest day 2... etc.
Upon withdrawal of life support, assessed up to 3 months postcardiac arrest
Post arrest neurological investigations (including imaging studies)
Time Frame: Performed within 21 days from cardiac arrest
All neurological investigations done within 21 days from cardiac arrest will be examined including electroencephalograms, somatosensory evoked potentials, brain magnetic resonance imaging, brain computerized tomography (CT) scans... etc.
Performed within 21 days from cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Eyad Althenayan, MD, Western University, Canada
  • Study Director: Philip Jones, MD, FRCPC, Western University, Canada
  • Study Chair: Bryan Young, MD, FRCPC, Western University, Canada
  • Study Director: Ahmed F Hegazy, MD, FRCPC, Western University, Canada
  • Study Director: Ana Igric, MD, FRCSC, Western University, Canada
  • Study Director: Carolyn Benson, MD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

January 4, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104666

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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