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

NCT02033720 | Unknown

• 1 other identifier: 104666
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postcardiac Arrest; Pulseless Electrical Activity; Asystole

Keywords

postcardiac arrest; post cardiac arrest syndrome; post cardiac arrest hypothermia; pulseless electrical activity; asystole; therapeutic hypothermia; therapeutic hypothermia after cardiac arrest; therapeutic hypothermia neurologic outcome

Outcome Measures

Primary Outcomes (1)

• Cerebral performance category score on hospital discharge

  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

Secondary Outcomes (3)

• Hospital length of stay postcardiac arrest

  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

  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

  Assessed up to 12 months from hospital discharge

Other Outcomes (3)

• Time to obeying commands

  Assessed up to 21 days postcardiac arrest

• Documented negative neurological prognosticators

  Upon withdrawal of life support, assessed up to 3 months postcardiac arrest

• Post arrest neurological investigations (including imaging studies)

  Performed within 21 days from cardiac arrest

Study Arms (3)

Shockable arrest

Initial arrest rhythm shockable. This is either pulseless ventricular tachycardia (pulseless VT) or ventricular fibrillation (VF).

Other: No treatment; Other: Therapeutic hypothermia

Pulseless electrical activity

Initial arrest rhythm is pulseless electrical activity.

Other: No treatment; Other: Therapeutic hypothermia

Asystole

Initial arrest rhythm is asystole.

Other: No treatment; Other: Therapeutic hypothermia

Interventions

No treatment OTHER

No therapeutic hypothermia was induced.

Also known as: No therapeutic hypothermia., Control.

Asystole; Pulseless electrical activity; Shockable arrest

Therapeutic hypothermia OTHER

Hypothermia was induced after successful resuscitation from cardiac arrest.

Also known as: Hypothermia, Induced hypothermia, Mild therapeutic hypothermia, Cooling, Targeted temperature management

Asystole; Pulseless electrical activity; Shockable arrest

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \- ICU admissions primarily for reasons other than cardiac arrest.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (2)

University Hospital, London Health Sciences Centre, University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

Victoria Hospital, London Health Sciences Centre, University of Western Ontario

London, Ontario, N6A 5W9, Canada

Location

Related Publications (7)

• 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.

  PMID: 20860507 BACKGROUND

• 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.

  PMID: 11856794 BACKGROUND

• 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.

  PMID: 11856793 BACKGROUND

• 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.

  PMID: 20956249 BACKGROUND

• 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.

  PMID: 17334257 BACKGROUND

• 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.

  PMID: 21705132 BACKGROUND

• 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.

  PMID: 21321156 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Post-Cardiac Arrest Syndrome

Interventions

Hypothermia, Induced; Cool-Down Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics; Post-Exercise Recovery Techniques; Physical Therapy Modalities; Rehabilitation; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eyad Althenayan, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

• Philip Jones, MD, FRCPC

  Western University, Canada

  STUDY DIRECTOR

• Bryan Young, MD, FRCPC

  Western University, Canada

  STUDY CHAIR

• Ahmed F Hegazy, MD, FRCPC

  Western University, Canada

  STUDY DIRECTOR

• Ana Igric, MD, FRCSC

  Western University, Canada

  STUDY DIRECTOR

• Carolyn Benson, MD

  Western University, Canada

  STUDY DIRECTOR

Central Study Contacts

Ahmed F Hegazy, MD, FRCPC

CONTACT

1(519) 860-4917; ahmed.hegazy@londonhospitals.ca

Eyad AlThenayan, MD

CONTACT

Eyad.Althenayan@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Eyad AlThenayan

Study Record Dates

• First Submitted: January 4, 2014
• First Posted: January 13, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

CA (2)