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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Ontario
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London、Ontario、カナダ、N6A 5A5
- University Hospital, London Health Sciences Centre, University of Western Ontario
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London、Ontario、カナダ、N6A 5W9
- Victoria Hospital, London Health Sciences Centre, University of Western Ontario
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：回顧
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Shockable arrest
Initial arrest rhythm shockable.
This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF).
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No therapeutic hypothermia was induced.
他の名前：
Hypothermia was induced after successful resuscitation from cardiac arrest.
他の名前：
|
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Pulseless electrical activity
Initial arrest rhythm is pulseless electrical activity.
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No therapeutic hypothermia was induced.
他の名前：
Hypothermia was induced after successful resuscitation from cardiac arrest.
他の名前：
|
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Asystole
Initial arrest rhythm is asystole.
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No therapeutic hypothermia was induced.
他の名前：
Hypothermia was induced after successful resuscitation from cardiac arrest.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cerebral performance category score on hospital discharge
時間枠：Upon discharge from hospital, assessed up to 36 months postcardiac arrest
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hospital length of stay postcardiac arrest
時間枠：Days spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
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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.
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Days spent in hospital after successful resuscitation from cardiac arrest, assessed up to 36 months from the date of cardiac arrest
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Intensive care unit length of stay postcardiac arrest
時間枠：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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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
時間枠：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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to obeying commands
時間枠：Assessed up to 21 days postcardiac arrest
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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
時間枠：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)
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Eyad Althenayan, MD、Western University, Canada
- スタディディレクター：Philip Jones, MD, FRCPC、Western University, Canada
- スタディチェア：Bryan Young, MD, FRCPC、Western University, Canada
- スタディディレクター：Ahmed F Hegazy, MD, FRCPC、Western University, Canada
- スタディディレクター：Ana Igric, MD, FRCSC、Western University, Canada
- スタディディレクター：Carolyn Benson, MD、Western University, Canada
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 104666
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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