None listed
Conditions
Brief summary
Furosemide (a loop diuretic) and Acetazolamide (a carbonic anhydrase inhibitor) are two commonly used diuretic drugs in the intensive care unit. Evidence suggests that giving Acetazolamide together with Furosemide has beneficial physiological effects. This multi-centre, cluster, crossover trial will assess a two-dose Acetazolamide regimen over 48 hours and focus on its physiological effects and evaluate patient outcomes, such as time spent in ICU and hospital. The trial will enrol approximately 144 patients from approximately 3 intensive care units in Australia and Japan. Each hospital will be randomly allocated to ‘Adjunctive acetazolamide’ arm or ‘Furosemide only’ arm. Each hospital will follow each Arm for a period of 6 months before swapping to the alternative regimen for 6 months. This is a crossover design. The trial will be complete in 12-months. Findings from this study will be used to improve diuretic management in the ICU and inform the design of future trials.
Interventions
Patients will receive a single dose of 500mg of acetazolamide intravenously administered simultaneously or within 2 hours of the indexed single furosemide dose delivered intravenously, followed by an additional single dose of 500mg acetazolamide intravenously at 24 hours after the first dose unless deceased or discharged from the intensive care unit
Sponsors
Dr Heidi Gaulke, Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged greater than 18 years Physician decision to administer furosemide for fluid management Anticipated intensive care unit stay for three consecutive days from enrolment Existing intra-arterial or central venous catheter Existing indwelling urinary catheter
Exclusion criteria
Known allergy to furosemide or acetazolamide or other sulphonamides Baseline etimate glomerular filtration rate less than 15 Dose of any diuretic in the preceding 6 hours Severe acidosis or hypokalaemia (pH less than 7.25) Hypokalaemia (potassium less than 2.5 mmol/L) Severe metabolic alkalosis (pH less than 7.5 and base excess greater than positive 5) Acute liver failure or high risk for hyperammonemia Prior renal replacement therapy during this intensive care unit admission Previous enrolment in this study Confirmed or suspected pregnancy Confirmed or suspected breast-feeding
Outcome results
None listed