None listed
Conditions
Brief summary
More than 20,000 heart operations are carried out each year in Australia. While many patients survive the operation, many spend long periods in hospital recovering. Common complications that can occur include a rapid and irregular heart rate (atrial fibrillation) and damage to the kidneys (known as acute kidney injury). These each occur in as many as one in four patients. Preventing or reducing the severity of these complications could improve the health of patients. Previous studies have suggested that acute kidney injury or atrial fibrillation may be reduced by using a drug known as ‘vasopressin’ to preserve blood pressure during surgery. Drugs to preserve blood pressure are often needed in cardiac surgery. However, the research studies that showed that vasopressin was a superior choice to noradrenaline were small, and the largest was conducted in a hospital and group of patients with a higher rate of complications. In this study we aim to assess whether a trial comparing vasopressin to a placebo infusion (inactive substance) is feasible in a Australian population.
Interventions
A vasopressin infusion started at a rate of 2IU/hr (2mls/hr). The infusion will be made up as 50 IU in 50mls of 0.9% saline. The study drug will be initiated after induction of anaesthesia and prior to institution of cardiopulmonary bypass . The study drug will be continued for up to 48 hours or until ready for discharge from ICU, whichever occurs sooner. The study drug drug will be run continuously. It may be paused at any point where reduced mean arterial pressure (MAP) is desirable. It may
A vasopressin infusion started at a rate of 2IU/hr (2mls/hr). The infusion will be made up as 50 IU in 50mls of 0.9% saline. The study drug will be initiated after induction of anaesthesia and prior to institution of cardiopulmonary bypass . The study drug will be continued for up to 48 hours or until ready for discharge from ICU, whichever occurs sooner. The study drug drug will be run continuously. It may be paused at any point where reduced mean arterial pressure (MAP) is desirable. It may be stopped if persistently high MAP >85mmHg is encountered. Adherence will be monitored by reviewing the electronic medical record. Specifically the anaesthetic record and ICU drug chart.
Sponsors
The Australian and New Zealand College of Anaesthetists Clinical Trials Network Pilot Grant.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults 18 years and over undergoing cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, combined CABG/valve surgery
Exclusion criteria
Major aortic surgery, transplant surgery, pulmonary endarterectomy, ventricular assist device placement; Already receiving inotropic/vasopressor support; dialysis dependent; pre-existing uncontrolled hypertension; pregnant or breastfeeding women; serum Na < 130mmol/l; ICU admission prior to surgery
Outcome results
None listed