None listed
Conditions
Brief summary
The purpose of the study is to help determine whether, in high risk patients undergoing cardiac surgery, a device known as an intraaortic balloon pump placed prior to surgery to support the heart, reduces serious postoperative complications. The study will also help determine whether a large study to definitively answer this question is feasible.
Interventions
For those trial participants randomized to prophylactic intraaortic balloon counterpulsation (IABC), an intraaortic balloon pump (IABP) will be inserted prior to the commencement of surgery. The timing of the placement of the IABP will be left to the discretion of the treating surgical team and depending on local facilities, policies and expertise, may be placed in the intensive care unit (ICU), cardiac catheter lab, anaesthetic bay or operating theatre (after induction of anaesthesia, but prior
For those trial participants randomized to prophylactic intraaortic balloon counterpulsation (IABC), an intraaortic balloon pump (IABP) will be inserted prior to the commencement of surgery. The timing of the placement of the IABP will be left to the discretion of the treating surgical team and depending on local facilities, policies and expertise, may be placed in the intensive care unit (ICU), cardiac catheter lab, anaesthetic bay or operating theatre (after induction of anaesthesia, but prior to commencement of the surgery). Details of the location and timing of insertion will be recorded. After confirmation of correct placement, IABC will commence 1:1 throughout the surgery and for the first post-operative night in the ICU. Removal of the IABP after the first night in the ICU will be at the discretion of the treating team. General care of the IABP will be according to local institutional policies and protocols.
Sponsors
Royal Perth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is listed for cardiac surgery that includes CABG 2. The treating surgical team considers prophylactic IABC may be of benefit 3. Either: Severely impaired left ventricular function of any cause Or: Recent or ongoing myocardial ischaemia+ Or: Critical coronary artery stenosis +myocardial ischaemia defined by pain at rest, requirement for IV GTN or heparin, or elevated troponin.
Exclusion criteria
1. Patient age <18 years 2. Patient has an IABC, ventricular assist device or ECMO circuit in situ 3. IABC placement is planned for an immediate therapeutic indication (e.g. cardiogenic shock, severe mitral regurgitation) 4. Absolute contraindication to IABC a. Severe bilateral lower limb peripheral vascular disease or bilateral femoral arterial grafting b. Moderate or severe aortic regurgitation c. Abdominal or thoracic aortic aneurysm, severe calcification or dissection d. Infection overlying bilateral femoral arteries 5. Treating clinician deems enrollment is not in the best interest of the patient 6. Death is imminent and inevitable 7. Weight <40kg 8. Patient is highly unlikely to be contactable at 6 months for follow up
Outcome results
None listed