Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
Information source: Bayside Health
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Arrest
Intervention: Automated CPR (Device); ECMO (Device); Coronary angiography (Procedure); Therapeutic Hypothermia (Procedure)
Phase: Phase 1
Status: Recruiting
Sponsored by: Bayside Health Official(s) and/or principal investigator(s): Stephen A Bernard, MBBS MD, Principal Investigator, Affiliation: The Alfred
Overall contact: Stephen A bernard, MBBS MD, Phone: 9076200, Email: s.bernard@alfred.org.au
Summary
Sudden out-of-hospital cardiac arrest (OHCA) is a leading cause of death in Australia. The
most common cause of OHCA is a heart attack. The current treatment of OHCA is resuscitation
by ambulance paramedics involving CPR, electrical shocks to the heart, and injections of
adrenaline. In more than 50% of cases, paramedics are unable to start the heart and the
patient is declared dead at the scene. Patients with OHCA who do not respond to paramedic
resuscitation are not routinely transported to hospital because it is hazardous for
paramedics to undertake rapid transport whilst administering chest compressions and there is
currently no additional therapy available at the hospital that would assist in starting the
heart.
However, a number of recent developments suggest that there may be a new approach to the
resuscitation of this group of patients who would otherwise die.
Firstly, Ambulance Victoria have recently introduced portable battery powered machines that
allow chest compressions to be safely and effectively delivered during emergency ambulance
transport.
Second, The Alfred ICU will shortly be implementing a new protocol whereby the patient in
cardiac arrest can immediately be placed on a heart-lung machine. This is known as
extra-corporeal membrane oxygenation (ECMO).
Third, the brain can now be much better protected against damage due to lack of blood flow
using therapeutic hypothermia which is the controlled lowering of body temperature from 37°C
to 33°C. Clinical trials have demonstrated that this significantly decreases brain damage
after OHCA.
Finally, The Alfred Cardiology service has an emergency service for reopening the blocked
artery of the heart in patients who present with a sudden blockage of the heart arteries.
This is currently not used in patients without a heart beat because of the technical
difficulty of undertaking this procedure with chest compressions being undertaken.
This study proposes for the first time to implement all the above interventions when
patients have failed standard resuscitation after OHCA. When standard resuscitation has
proved futile, the patient will be transported to The Alfred with the mechanical chest
compression device, cooled to 33°C, placed on ECMO, and then transported to the
interventional cardiac catheter laboratory. The patient will then receive therapeutic
hypothermia for 24 hours. Subsequent management will follow the standard treatment
guidelines of The Alfred Intensive Care Unit.
Clinical Details
Official title: Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Survival to hospital discharge
Secondary outcome: Neurologic recoveryTime until ECMO insertion neurologic biomarkers Cardiac recovery
Eligibility
Minimum age: 18 Years.
Maximum age: 59 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults 18-59 years
- Out of hospital cardiac arrest due to presumed cardiac caus
- Chest compressions are commenced within 10 minutes by bystanders or emergency
medical services
- Initial cardiac arrest rhythm of ventricular fibrillation
- Remains in cardiac arrest at the scene at 20 minutes after standard paramedic
advanced cardiac life support (intubation, intravenous adrenaline)
- Autopulse machine is available
- Within 10 minutes ambulance transport time to The Alfred
- During normal working hours (9am-5pm, Monday to Friday)
- ECMO commences within 60 minutes of the initial collapse
Exclusion Criteria:
- Presumed non-cardiac cause of cardiac arrest such as trauma, hanging, drowning,
intracranial bleeding
- Any pre-existing significant neurological disability
- Significant non-cardiac co-morbidities that cause limitations in activities of daily
living such as COPD, cirrhosis of the liver, renal failure on dialysis, terminal
illness due to malignancy
Locations and Contacts
Stephen A bernard, MBBS MD, Phone: 9076200, Email: s.bernard@alfred.org.au
Alfred Hospital, Melbourne, Victoria 3161, Australia; Recruiting Stephen Bernard, MBBS MD, Phone: 90762000 Stephen A Bernard, MBBS MD, Principal Investigator Dion A Stub, MBBS, Sub-Investigator Vincent Pellegrino, MBBS, Sub-Investigator Lisen Hockings, MBBS, Sub-Investigator Matthew Reid, RN, Sub-Investigator David M Kaye, MBBS PhD, Sub-Investigator Stephen J Duffy, MBBS PhD, Sub-Investigator Peter Cameron, MBBS MD, Sub-Investigator De Villiers Smit, MBBS, Sub-Investigator
Ambulance Victoria, Melbourne, Victoria, Australia; Not yet recruiting Karen Smith, BSc PhD, Phone: 9840 3752, Email: karen.smith@ambulance.vic.gov.au Karen Smith, BSc PhD, Sub-Investigator Tony Walker, HlthSci MICA, Sub-Investigator
Additional Information
Starting date: November 2010
Last updated: March 6, 2014
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