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

NCT01186614 | Unknown Phase 1 DMC

• 1 other identifier: project 160/10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Survival to hospital discharge

  At hospital discharge

Secondary Outcomes (4)

• Neurologic recovery

  At discharge

• Time until ECMO insertion

  On admission

• neurologic biomarkers

  Day 3

• Cardiac recovery

  Days 1, 3, 5

Study Arms (1)

Novel treatment paradigm

EXPERIMENTAL

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

Device: Automated CPR; Device: ECMO; Procedure: Coronary angiography; Procedure: Therapeutic Hypothermia

Interventions

Automated CPR DEVICE

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

Also known as: Zoll Autopulse

Novel treatment paradigm

ECMO DEVICE

Insertion of peripheral VA ECMO

Novel treatment paradigm

Coronary angiography PROCEDURE

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

Novel treatment paradigm

Therapeutic Hypothermia PROCEDURE

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

Novel treatment paradigm

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead
• The Alfred: collaborator
• Ambulance Victoria: collaborator

Study Sites (2)

Alfred Hospital

Melbourne, Victoria, 3161, Australia

RECRUITING

Ambulance Victoria

Melbourne, Victoria, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Stephen A Bernard, MBBS MD

  The Alfred

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen A bernard, MBBS MD

CONTACT

9076200; s.bernard@alfred.org.au

Dion A Stub, MBBS

CONTACT

90762000; d.stub@alfred.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Ethics Unit

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 23, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

AU (2)