Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion (CHEER)

This study is currently recruiting participants.
Verified March 2014 by Bayside Health
Sponsor:
Collaborators:
The Alfred
Ambulance Victoria
Information provided by (Responsible Party):
Ms. Rowan Frew, Bayside Health
ClinicalTrials.gov Identifier:
NCT01186614
First received: August 20, 2010
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
Device: Automated CPR
Device: ECMO
Procedure: Coronary angiography
Procedure: Therapeutic Hypothermia
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Survival to hospital discharge [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurologic recovery [ Time Frame: At discharge ] [ Designated as safety issue: No ]
    Assessed by cerebral performance category

  • Time until ECMO insertion [ Time Frame: On admission ] [ Designated as safety issue: No ]
  • neurologic biomarkers [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    neuron-specific enolase and S100β

  • Cardiac recovery [ Time Frame: Days 1, 3, 5 ] [ Designated as safety issue: No ]
    measured by echocardiography and cardiac biomakers including troponin, CK and BNP


Estimated Enrollment: 24
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Novel treatment paradigm
treatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention
Device: Automated CPR
Automated CPR utilised by paramedics to facilitate CPR during transport to hospital
Other Name: Zoll Autopulse
Device: ECMO
Insertion of peripheral VA ECMO
Procedure: Coronary angiography
Coronary angiography and intervention where necessary will be performed following ECMO insertion
Procedure: Therapeutic Hypothermia
Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186614

Contacts
Contact: Stephen A bernard, MBBS MD 9076200 s.bernard@alfred.org.au
Contact: Dion A Stub, MBBS 90762000 d.stub@alfred.org.au

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3161
Contact: Stephen Bernard, MBBS MD    90762000      
Principal Investigator: Stephen A Bernard, MBBS MD         
Sub-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         
Ambulance Victoria Not yet recruiting
Melbourne, Victoria, Australia
Contact: Karen Smith, BSc PhD    9840 3752    karen.smith@ambulance.vic.gov.au   
Sub-Investigator: Karen Smith, BSc PhD         
Sub-Investigator: Tony Walker, HlthSci MICA         
Sponsors and Collaborators
Bayside Health
The Alfred
Ambulance Victoria
Investigators
Principal Investigator: Stephen A Bernard, MBBS MD The Alfred
  More Information

No publications provided

Responsible Party: Ms. Rowan Frew, Director of Research and Ethics Unit, Bayside Health
ClinicalTrials.gov Identifier: NCT01186614     History of Changes
Other Study ID Numbers: project 160/10
Study First Received: August 20, 2010
Last Updated: March 6, 2014
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
cardiac arrest
ECMO
hypothermia
automated CPR
coronary intervention

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014