None listed
Conditions
Brief summary
More than 20,000 heart operations are carried out each year in Australia. While most patients survive their surgery, many spend a long period of time in hospital recovering. Delayed recovery may happen as a result of the complexity of the surgery, or due to medical problems that occur after the operation such as irregular heart rhythms, stroke or kidney failure. These medical problems following surgery are known as postoperative complications. Postoperative complications can lead to long-term ill health and loss of independence, as well as prolonging hospital stay. In addition, a longer stay in hospital may expose patients to risks such as infection and predispose to physical deconditioning. Reducing length of stay in hospital is associated with improved recovery from surgery, in addition to reduced healthcare costs. Previous studies have suggested that a new drug called ‘angiotensin II’ can successfully be used to treat low blood pressure in critically unwell patients. Drugs to preserve blood pressure are also often needed in heart surgery, however there are no large studies that have assessed the effectiveness of angiotensin II in patients during and after heart surgery. We previously carried out a small study that showed that using the drug angiotensin II during and after cardiac surgery is possible (ACTRN12621000195853). This knowledge has allowed us to design a new study to compare the use of angiotensin II to the current standard drug used to treat low blood pressure after heart surgery, called noradrenaline. In our previous research, patients who were given angiotensin II had fewer postoperative complications (although this difference wasn't statistically significant) and shorter lengths of stay in hospital. However, before we can recommend that angiotensin II is better for treatment of low blood pressure during cardiac surgery, we need to confirm these findings in a much larger study to make sure that our previous study findings were not simply the result of chance. In this study we will assess whether the administration of angiotensin II reduces length of hospital stay compared to noradrenaline.
Interventions
Angiotensin II intravenous infusion titrated to a systemic mean arterial pressure of 70 - 80 mmHg in a dose range of 0-80ng/kg/min starting after induction of anaesthesia and prior to start of surgery and continuing for 48 hours after induction of anaesthesia
Study drug administration adherence as recorded in case report form
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Coronary artery bypass grafting (CABG) surgery, valve repair or replacement (VR) surgery or a combination of CABG and VR surgery 2. Elevated risk of acute kidney injury as predicted by any of the following: a) Haemoglobin <130g/l b) Creatinine > 100mmol/l c) Age > 70 years d) New York Heart Association classification 4 e) Body Mass Index > 30 kg/m2
Exclusion criteria
1. Major aortic surgery, transplant surgery, pulmonary thrombendarterectomy or ventricular assist device surgery 2. Already receiving inotropic or vasopressor support 3. Dialysis dependent, prior renal transplant 4. Pre-existing significant hypertension (systolic blood pressure > 180mm Hg) 5. Significant pulmonary hypertension (estimated systolic pulmonary artery pressure (PAP) > 70mmHg, mean PAP > 40mmHg) AND right ventricular systolic dysfunction (graded more severe than mild) 6. Pregnant or breastfeeding women
Outcome results
None listed