Trial record 2 of 167 for:    Open Studies | "Heart Arrest"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Lawson Health Research Institute
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Eyad AlThenayan, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT02033720
First received: January 4, 2014
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Postcardiac Arrest
Pulseless Electrical Activity
Asystole
Other: No treatment
Other: Therapeutic hypothermia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Neurological Outcomes After Cardiac Arrest in Pulseless Electrical Activity in Comparison to Asystole. Are All Non-shockable Rhythms the Same?

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Cerebral performance category score on hospital discharge [ Time Frame: Upon discharge from hospital, assessed up to 36 months postcardiac arrest ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    The length of stay (LOS) in the intensive care unit (ICU) in days, after successful resuscitation from cardiac arrest.

  • Neurological status after hospital discharge [ Time Frame: Assessed up to 12 months from hospital discharge ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Time to obeying commands [ Time Frame: Assessed up to 21 days postcardiac arrest ] [ Designated as safety issue: No ]
    Total time in days from the cardiac arrest until the patient is able to obey commands, as documented in the patient's chart.

  • Documented negative neurological prognosticators [ Time Frame: Upon withdrawal of life support, assessed up to 3 months postcardiac arrest ] [ Designated as safety issue: No ]

    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.


  • Post arrest neurological investigations (including imaging studies) [ Time Frame: Performed within 21 days from cardiac arrest ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  • Therapeutic 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
  • Therapeutic 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
  • Therapeutic hypothermia
  • Mild therapeutic hypothermia
  • Cooling
  • Targeted temperature management

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033720

Contacts
Contact: Ahmed F Hegazy, MD, FRCPC 1(519) 860-4917 ahmed.hegazy@londonhospitals.ca
Contact: Eyad AlThenayan, MD Eyad.Althenayan@lhsc.on.ca

Locations
Canada, Ontario
University Hospital, London Health Sciences Centre, University of Western Ontario Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Ahmed F Hegazy, MD, FRCPC    1(519) 860-4917    ahmed.hegazy@londonhospitals.ca   
Contact: Eyad Althenayan, MD    1 (519) 685-8500 ext 19119    eyad.althenayan@lhsc.on.ca   
Sub-Investigator: Ahmed F Hegazy, MD, FRCPC         
Victoria Hospital, London Health Sciences Centre, University of Western Ontario Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Ahmed F Hegazy, MD, FRCPC    1(519) 860-4917    ahmed.hegazy@londonhospitals.ca   
Contact: Eyad Althenayan, MD    1 (519) 685-8500 ext 19119    eyad.althenayan@lhsc.on.ca   
Sub-Investigator: Ahmed F Hegazy, MD, FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Eyad Althenayan, MD University of Western Ontario, Canada
Study Director: Philip Jones, MD, FRCPC University of Western Ontario, Canada
Study Chair: Bryan Young, MD, FRCPC University of Western Ontario, Canada
Study Director: Ahmed F Hegazy, MD, FRCPC University of Western Ontario, Canada
Study Director: Ana Igric, MD, FRCSC University of Western Ontario, Canada
Study Director: Carolyn Benson, MD University of Western Ontario, Canada
  More Information

Publications:

Responsible Party: Eyad AlThenayan, Dr. Eyad AlThenayan, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT02033720     History of Changes
Other Study ID Numbers: 104666
Study First Received: January 4, 2014
Last Updated: January 9, 2014
Health Authority: Canada: University of Western Ontario

Keywords provided by Lawson Health Research Institute:
postcardiac arrest
post cardiac arrest syndrome
post cardiac arrest hypothermia
pulseless electrical activity
asystole
therapeutic hypothermia
therapeutic hypothermia after cardiac arrest
therapeutic hypothermia neurologic outcome

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014