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?
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Ontario
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London, Ontario, Canada, N6A 5A5
- University Hospital, London Health Sciences Centre, University of Western Ontario
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London, Ontario, Canada, N6A 5W9
- Victoria Hospital, London Health Sciences Centre, University of Western Ontario
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Shockable arrest
Initial arrest rhythm shockable.
This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF).
|
No therapeutic hypothermia was induced.
Andre navn:
Hypothermia was induced after successful resuscitation from cardiac arrest.
Andre navn:
|
|
Pulseless electrical activity
Initial arrest rhythm is pulseless electrical activity.
|
No therapeutic hypothermia was induced.
Andre navn:
Hypothermia was induced after successful resuscitation from cardiac arrest.
Andre navn:
|
|
Asystole
Initial arrest rhythm is asystole.
|
No therapeutic hypothermia was induced.
Andre navn:
Hypothermia was induced after successful resuscitation from cardiac arrest.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cerebral performance category score on hospital discharge
Tidsramme: 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:
|
Upon discharge from hospital, assessed up to 36 months postcardiac arrest
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital length of stay postcardiac arrest
Tidsramme: 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
Tidsramme: 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.
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Days spent in the intensive care unit after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
|
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Neurological status after hospital discharge
Tidsramme: Assessed up to 12 months from hospital discharge
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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.
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Assessed up to 12 months from hospital discharge
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to obeying commands
Tidsramme: 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.
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Assessed up to 21 days postcardiac arrest
|
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Documented negative neurological prognosticators
Tidsramme: Upon withdrawal of life support, assessed up to 3 months postcardiac arrest
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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
|
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Post arrest neurological investigations (including imaging studies)
Tidsramme: Performed within 21 days from cardiac arrest
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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.
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Performed within 21 days from cardiac arrest
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Eyad Althenayan, MD, Western University, Canada
- Studieleder: Philip Jones, MD, FRCPC, Western University, Canada
- Studiestol: Bryan Young, MD, FRCPC, Western University, Canada
- Studieleder: Ahmed F Hegazy, MD, FRCPC, Western University, Canada
- Studieleder: Ana Igric, MD, FRCSC, Western University, Canada
- Studieleder: Carolyn Benson, MD, Western University, Canada
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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. Erratum In: N Engl J Med 2002 May 30;346(22):1756.
- 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.
Studierekorddatoer
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Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
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Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 104666
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