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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: Automated CPR; Device: ECMO; Procedure: Coronary angiography; Procedure: Therapeutic Hypothermia

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Stephen A bernard, MBBS MD; Phone Number: 9076200; Email: s.bernard@alfred.org.au
• Study Contact Backup: Name: Dion A Stub, MBBS; Phone Number: 90762000; Email: d.stub@alfred.org.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3161
      • Recruiting
      • Alfred Hospital
      • Contact: Stephen Bernard, MBBS MD; Phone Number: 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
    • Melbourne, Victoria, Australia
      • Not yet recruiting
      • Ambulance Victoria
      • Contact: Karen Smith, BSc PhD; Phone Number: 9840 3752; Email: karen.smith@ambulance.vic.gov.au
      • Sub-Investigator: Karen Smith, BSc PhD
      • Sub-Investigator: Tony Walker, HlthSci MICA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival to hospital discharge	At hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic recovery	Assessed by cerebral performance category	At discharge
Time until ECMO insertion		On admission
neurologic biomarkers	neuron-specific enolase and S100β	Day 3
Cardiac recovery	measured by echocardiography and cardiac biomakers including troponin, CK and BNP	Days 1, 3, 5

Collaborators and Investigators

• Sponsor: Bayside Health
• Collaborators: The Alfred; Ambulance Victoria
• Investigators: Principal Investigator: Stephen A Bernard, MBBS MD, The Alfred

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2014
• Last Update Submitted That Met QC Criteria: March 6, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: ECMO; cardiac arrest; hypothermia; coronary intervention; automated CPR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Heart Arrest; Hypothermia; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: project 160/10