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

Cardiac Arrest Clinical Trial

— CHEER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01186614
• Other study ID #: project 160/10
• Status: Recruiting
• Phase: Phase 1
• First received: August 20, 2010
• Last updated: March 6, 2014
• Start date: November 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Bayside Health
• Contact: Stephen A bernard, MBBS MD
• Phone: 9076200
• Email: s.bernard[@]alfred.org.au
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• Automated CPR
Automated CPR utilised by paramedics to facilitate CPR during transport to hospital
• ECMO
Insertion of peripheral VA ECMO

Procedure:
• Coronary angiography
Coronary angiography and intervention where necessary will be performed following ECMO insertion
• Therapeutic Hypothermia
Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Ambulance Victoria	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Bayside Health	Ambulance Victoria, The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to hospital discharge		At hospital discharge	No
Secondary	Neurologic recovery	Assessed by cerebral performance category	At discharge	No
Secondary	Time until ECMO insertion		On admission	No
Secondary	neurologic biomarkers	neuron-specific enolase and S100ß	Day 3	No
Secondary	Cardiac recovery	measured by echocardiography and cardiac biomakers including troponin, CK and BNP	Days 1, 3, 5	No