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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02033720
Enrollment
400
Registered
2014-01-13
Start date
2014-01-31
Completion date
2015-02-28
Last updated
2014-01-13

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

Conditions

Postcardiac Arrest, Pulseless Electrical Activity, Asystole

Keywords

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

Brief summary

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.

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.

Interventions

OTHERNo treatment

No therapeutic hypothermia was induced.

Hypothermia was induced after successful resuscitation from cardiac arrest.

Sponsors

University of Western Ontario, Canada
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral performance category score on hospital dischargeUpon discharge from hospital, assessed up to 36 months postcardiac arrestNeurological 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

MeasureTime frameDescription
Hospital length of stay postcardiac arrestDays spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrestHospital 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 arrestDays spent in the intensive care unit after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrestThe length of stay (LOS) in the intensive care unit (ICU) in days, after successful resuscitation from cardiac arrest.
Neurological status after hospital dischargeAssessed up to 12 months from hospital dischargeNeurological 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

MeasureTime frameDescription
Time to obeying commandsAssessed up to 21 days postcardiac arrestTotal 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 prognosticatorsUpon withdrawal of life support, assessed up to 3 months postcardiac arrestFor 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)Performed within 21 days from cardiac arrestAll 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.

Countries

Canada

Contacts

Primary ContactAhmed F Hegazy, MD, FRCPC
ahmed.hegazy@londonhospitals.ca1(519) 860-4917
Backup ContactEyad AlThenayan, MD
Eyad.Althenayan@lhsc.on.ca

Outcome results

None listed

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