None listed
Conditions
Brief summary
Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating form of haemorrhagic stroke, that results from bleeding from an intracranial aneurysm. A common complication of aSAH is hyponatremia with a reported prevalence of between 35% to 77%.Our group has recently demonstrated that patients in whom the sodium concentration decreases over the ICU stay have a higher likelihood of a worse outcome at 6-months compared to those patients in whom the sodium concentration remains steady. Fludrocortisone is a synthetic adrenocortical steroid possessing activity which produces significant sodium and fluid retention. Previous studies of fludrocortisone have demonstrated a reduction in hyponatraemia and fluid loss, but these studies were underpowered to show a clinical outcome benefit. Fludrocortisone therefore has the potential to prevent the onset of hyponatraemia in aSAH and lead to improved outcomes; however, this has never been tested in an adequately designed trial. This proposal is for a Phase 2 trial to examine the effect of fludrocortisone administration on serum sodium concentrations, fluid balance and clinical outcomes measures in patients with aSAH.
Interventions
Fludrocortisone 100µg tablet six hourly for fourteen days.
Sponsors
Metro North Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Diagnosed with aneurysmal subarachnoid haemorrhage (aSAH) from an aneurysm confirmed on computed tomography angiography (CTA) or digital subtraction angiography (DSA) of the intra-cranial arteries 3. Admitted to an Intensive Care or High Dependency Unit 4. Hospital admission for aneurysmal subarachnoid haemorrhage within 96 hours
Exclusion criteria
1. Unable to receive enteral medications 2. Pre-existing glucocorticoid or mineralocorticoid treatment (excluding inhaled) 3. Previous allergic reaction to fludrocortisone 4. Hospital admission for aSAH greater than 96 hours ago 5. History of cardiac, hepatic or renal failure 6. Hypernatraemia (Na>145mol/L) on the most recent blood sample at the time of screening. 7. Death deemed imminent or inevitable 8. Pregnancy (confirmed or suspected) 9. Documented systemic fungal infection 10. Previous enrolment in the trial
Outcome results
None listed