None listed
Conditions
Brief summary
Each year more than 25,000 Australians have cardiac surgery. While the mortality rate is relatively low (around 1-2%), the rate of problems afterwards such as kidney injury is higher (up to 40%). Acute kidney injury (AKI) is a reduction in kidney function over a short period of time. In many cases it resolves, but patients who have had AKI have higher rates of long-term kidney problems and mortality rates. A few will need dialysis. Maintaining blood flow and pressure for the kidney may help prevent injury. Angiotensin II is produced by the body naturally but can also be given as a drug. It has effects that increase blood pressure. Studies in patients with infection have shown that angiotensin II may improve kidney injury. Animal experiments suggest it may be superior to another drug, known as noradrenaline. Our hypothesis is that angiotensin II may reduce kidney injury. In this pilot study we will determine the feasibility of a definitive study comparing angiotensin II to noradrenaline.
Interventions
Angiotensin II infusion - dose to maintain mean arterial pressure in range of 70-80mmHg. Dose range 0-40ng/kg/min (titrated to maintain blood pressure in range). Started post-induction of anaesthesia and prior to initiation of cardiopulmonary bypass and continued for 48 hours after conclusion of surgery (as a continuous infusion), or until patient goes to the ward if this occurs sooner. Adherence reviewed by monitoring of electronic record. No other drugs administered as part of the intervention
Angiotensin II infusion - dose to maintain mean arterial pressure in range of 70-80mmHg. Dose range 0-40ng/kg/min (titrated to maintain blood pressure in range). Started post-induction of anaesthesia and prior to initiation of cardiopulmonary bypass and continued for 48 hours after conclusion of surgery (as a continuous infusion), or until patient goes to the ward if this occurs sooner. Adherence reviewed by monitoring of electronic record. No other drugs administered as part of the intervention.
Sponsors
Austin 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
Adult > 18 years old; Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, combined CABG/valve surgery; Elevated risk of acute kidney injury (AKI) as predicted by a score >3 on the following scale (ie. 3.5 or greater): - haemoglobin < 130g/l (2 points), creatinine >100umol/l (2 points), age > 70 (1.5 points), NYHA 4 (1.5 points), BMI > 30 (1.5points)
Exclusion criteria
- Major aortic surgery, transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement - Already receiving inotropic/vasopressor support - Dialysis dependent - Pre-existing uncontrolled hypertension - Asthma with lung function tests demonstrating reversible airway obstruction or a history of admission to hospital with asthma exacerbations - Severe LV systolic dysfunction (LVEF <30%) - Significant pulmonary hypertension (ePSAP > 70mmHg, mPAP > 40mmHg) - Pregnant or breastfeeding women
Outcome results
None listed