Study of Survivors of Different Types of Cardiac Arrest and Their Neurological Recovery
NCT ID: NCT02033720
Last Updated: 2014-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2014-01-31
2015-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Shockable arrest
Initial arrest rhythm shockable. This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF).
No treatment
No therapeutic hypothermia was induced.
Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Pulseless electrical activity
Initial arrest rhythm is pulseless electrical activity.
No treatment
No therapeutic hypothermia was induced.
Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Asystole
Initial arrest rhythm is asystole.
No treatment
No therapeutic hypothermia was induced.
Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Interventions
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No treatment
No therapeutic hypothermia was induced.
Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of Western Ontario, Canada
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Eyad AlThenayan
Dr. Eyad AlThenayan
Principal Investigators
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Eyad Althenayan, MD
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Philip Jones, MD, FRCPC
Role: STUDY_DIRECTOR
Western University, Canada
Bryan Young, MD, FRCPC
Role: STUDY_CHAIR
Western University, Canada
Ahmed F Hegazy, MD, FRCPC
Role: STUDY_DIRECTOR
Western University, Canada
Ana Igric, MD, FRCSC
Role: STUDY_DIRECTOR
Western University, Canada
Carolyn Benson, MD
Role: STUDY_DIRECTOR
Western University, Canada
Locations
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University Hospital, London Health Sciences Centre, University of Western Ontario
London, Ontario, Canada
Victoria Hospital, London Health Sciences Centre, University of Western Ontario
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Holzer M. Targeted temperature management for comatose survivors of cardiac arrest. N Engl J Med. 2010 Sep 23;363(13):1256-64. doi: 10.1056/NEJMct1002402. No abstract available.
Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
Hazinski MF, Nolan JP, Billi JE, Bottiger BW, Bossaert L, de Caen AR, Deakin CD, Drajer S, Eigel B, Hickey RW, Jacobs I, Kleinman ME, Kloeck W, Koster RW, Lim SH, Mancini ME, Montgomery WH, Morley PT, Morrison LJ, Nadkarni VM, O'Connor RE, Okada K, Perlman JM, Sayre MR, Shuster M, Soar J, Sunde K, Travers AH, Wyllie J, Zideman D. Part 1: Executive summary: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S250-75. doi: 10.1161/CIRCULATIONAHA.110.970897. No abstract available.
Arrich J; European Resuscitation Council Hypothermia After Cardiac Arrest Registry Study Group. Clinical application of mild therapeutic hypothermia after cardiac arrest. Crit Care Med. 2007 Apr;35(4):1041-7. doi: 10.1097/01.CCM.0000259383.48324.35.
Testori C, Sterz F, Behringer W, Haugk M, Uray T, Zeiner A, Janata A, Arrich J, Holzer M, Losert H. Mild therapeutic hypothermia is associated with favourable outcome in patients after cardiac arrest with non-shockable rhythms. Resuscitation. 2011 Sep;82(9):1162-7. doi: 10.1016/j.resuscitation.2011.05.022. Epub 2011 Jun 12.
Dumas F, Grimaldi D, Zuber B, Fichet J, Charpentier J, Pene F, Vivien B, Varenne O, Carli P, Jouven X, Empana JP, Cariou A. Is hypothermia after cardiac arrest effective in both shockable and nonshockable patients?: insights from a large registry. Circulation. 2011 Mar 1;123(8):877-86. doi: 10.1161/CIRCULATIONAHA.110.987347. Epub 2011 Feb 14.
Other Identifiers
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104666
Identifier Type: -
Identifier Source: org_study_id
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