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

9. januar 2014 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Shockable arrest
Initial arrest rhythm shockable. This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF).
Andet: No treatment
No therapeutic hypothermia was induced.
Andre navne:
  • No therapeutic hypothermia.
  • Styring.
Andet: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Andre navne:
  • Hypotermi
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Køling
  • Targeted temperature management
Pulseless electrical activity
Initial arrest rhythm is pulseless electrical activity.
Andet: No treatment
No therapeutic hypothermia was induced.
Andre navne:
  • No therapeutic hypothermia.
  • Styring.
Andet: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Andre navne:
  • Hypotermi
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Køling
  • Targeted temperature management
Asystole
Initial arrest rhythm is asystole.
Andet: No treatment
No therapeutic hypothermia was induced.
Andre navne:
  • No therapeutic hypothermia.
  • Styring.
Andet: Therapeutic hypothermia
Hypothermia was induced after successful resuscitation from cardiac arrest.
Andre navne:
  • Hypotermi
  • Induced hypothermia
  • Mild therapeutic hypothermia
  • Køling
  • Targeted temperature management

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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:

  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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
Assessed up to 21 days postcardiac arrest
Documented negative neurological prognosticators
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lawson Health Research Institute

Samarbejdspartnere

University of Western Ontario, Canada

Efterforskere

  • Ledende efterforsker: 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Forventet)

1. december 2014

Studieafslutning (Forventet)

1. februar 2015

Datoer for studieregistrering

Først indsendt

4. januar 2014

Først indsendt, der opfyldte QC-kriterier

9. januar 2014

Først opslået (Skøn)

13. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 104666

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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