None listed
Conditions
Brief summary
Hypothesis and Outcomes: This study will test the primary hypothesis that nebulised heparin improves lung function, assessed by the change in the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) over the operative period. Secondary outcomes include the extent of post-operative organ supports and duration of intensive care and hospital stays. Significance: Nebulised heparin offers the possibility of a cost-effective strategy to prevent respiratory failure developing in patients following heart surgery. Health benefits and healthcare cost savings could be substantial. An effective strategy could save the Australian healthcare system at least $8.5 million per year in intensive care costs alone.
Interventions
a single dose of nebulised heparin (50,000 IU in 10 ml) or placebo (0.9% sodium chloride 10 ml) will be administered following anaesthetic induction.
Sponsors
Barwon Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
coronary artery bypass grafting (CABG) with 4 or more grafts or a combined procedure of CABG with open aortic valve replacement.
Exclusion criteria
Allergy to heparin; any history of heparin induced thrombocytopenia Renal impairment (defined as creatinine >130 umol/L) Planned to receive pre-operative heparin Receiving systemic immunosuppressant (such as steroids, cyclosporine, azathioprine) Marked limitation of physical activity: defined as development of fatigue or shortness of breath on walking 100 meters.
Outcome results
None listed