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

• ClinicalTrials.gov Identifier: NCT01186614
• Recruitment Status: Unknown
• First Posted: August 23, 2010
• Last Update Posted: March 10, 2014
• Sponsor: Bayside Health
• Collaborators: The Alfred; Ambulance Victoria
• Information provided by (Responsible Party): Ms. Rowan Frew, Bayside Health

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest	Device: Automated CPR; Device: ECMO; Procedure: Coronary angiography; Procedure: Therapeutic Hypothermia	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
• Study Start Date: November 2010
• Estimated Primary Completion Date: July 2014
• Estimated Study Completion Date: December 2014

Arms and Interventions

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 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)

Outcome Measures

Primary Outcome Measures :

1. Survival to hospital discharge [ Time Frame: At hospital discharge ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Ms. Rowan Frew, Director of Research and Ethics Unit, Bayside Health
• ClinicalTrials.gov Identifier: NCT01186614
• Other Study ID Numbers: project 160/10
• First Posted: August 23, 2010
• Last Update Posted: March 10, 2014
• Last Verified: March 2014

Keywords provided by Ms. Rowan Frew, Bayside Health:

cardiac arrest; ECMO; hypothermia; automated CPR; coronary intervention

Additional relevant MeSH terms:

Heart Arrest; Out-of-Hospital Cardiac Arrest; Hypothermia; Heart Diseases; Cardiovascular Diseases; Body Temperature Changes