Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

9 gennaio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

400

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University Hospital, London Health Sciences Centre, University of Western Ontario
      • London, Ontario, Canada, N6A 5W9
        • Victoria Hospital, London Health Sciences Centre, University of Western Ontario

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Retrospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Shockable arrest
Initial arrest rhythm shockable. This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF).
Altro: No treatment
No therapeutic hypothermia was induced.
Altri nomi:
  • No therapeutic hypothermia.
  • Controllo.
Altro: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Altri nomi:
  • Ipotermia
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Raffreddamento
  • Targeted temperature management
Pulseless electrical activity
Initial arrest rhythm is pulseless electrical activity.
Altro: No treatment
No therapeutic hypothermia was induced.
Altri nomi:
  • No therapeutic hypothermia.
  • Controllo.
Altro: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Altri nomi:
  • Ipotermia
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Raffreddamento
  • Targeted temperature management
Asystole
Initial arrest rhythm is asystole.
Altro: No treatment
No therapeutic hypothermia was induced.
Altri nomi:
  • No therapeutic hypothermia.
  • Controllo.
Altro: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Altri nomi:
  • Ipotermia
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Raffreddamento
  • Targeted temperature management

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cerebral performance category score on hospital discharge
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hospital length of stay postcardiac arrest
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to obeying commands
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Lawson Health Research Institute

Collaboratori

University of Western Ontario, Canada

Investigatori

  • Investigatore principale: Eyad Althenayan, MD, Western University, Canada
  • Direttore dello studio: Philip Jones, MD, FRCPC, Western University, Canada
  • Cattedra di studio: Bryan Young, MD, FRCPC, Western University, Canada
  • Direttore dello studio: Ahmed F Hegazy, MD, FRCPC, Western University, Canada
  • Direttore dello studio: Ana Igric, MD, FRCSC, Western University, Canada
  • Direttore dello studio: Carolyn Benson, MD, Western University, Canada

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2014

Completamento primario (Anticipato)

1 dicembre 2014

Completamento dello studio (Anticipato)

1 febbraio 2015

Date di iscrizione allo studio

Primo inviato

4 gennaio 2014

Primo inviato che soddisfa i criteri di controllo qualità

9 gennaio 2014

Primo Inserito (Stima)

13 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 gennaio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 gennaio 2014

Ultimo verificato

1 gennaio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 104666

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su No treatment

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United States

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi