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

NCT ID: NCT01186614

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-12-31

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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Novel treatment paradigm

treatment protocol including - mechanical CPR, therapeutic hypothermia, ECMO, coronary intervention

Group Type: EXPERIMENTAL

Automated CPR

Intervention Type: DEVICE

Automated CPR utilised by paramedics to facilitate CPR during transport to hospital

ECMO

Intervention Type: DEVICE

Insertion of peripheral VA ECMO

Coronary angiography

Intervention Type: PROCEDURE

Coronary angiography and intervention where necessary will be performed following ECMO insertion

Therapeutic Hypothermia

Intervention Type: PROCEDURE

Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)

Interventions

Automated CPR

Automated CPR utilised by paramedics to facilitate CPR during transport to hospital

Intervention Type: DEVICE

ECMO

Insertion of peripheral VA ECMO

Intervention Type: DEVICE

Coronary angiography

Coronary angiography and intervention where necessary will be performed following ECMO insertion

Intervention Type: PROCEDURE

Therapeutic Hypothermia

Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)

Intervention Type: PROCEDURE

Other Intervention Names

Zoll Autopulse

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: collaborator

Ambulance Victoria

OTHER_GOV

Sponsor Role: collaborator

Bayside Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ms. Rowan Frew

Director of Research and Ethics Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen A Bernard, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Site Status: RECRUITING

Ambulance Victoria

Melbourne, Victoria, Australia

Site Status: NOT_YET_RECRUITING

Countries

Australia

Central Contacts

Stephen A bernard, MBBS MD

Role: CONTACT

s.bernard@alfred.org.au

9076200

Dion A Stub, MBBS

Role: CONTACT

d.stub@alfred.org.au

90762000

Facility Contacts

Stephen Bernard, MBBS MD

Role: primary

90762000

Karen Smith, BSc PhD

Role: primary

karen.smith@ambulance.vic.gov.au

9840 3752

Other Identifiers

project 160/10

Identifier Type: -

Identifier Source: org_study_id