Fludrocortisone treatment in patients with aneurysmal sub arachnoid haemorrhage
Effect of treatment with fludrocortisone on the incidence of hyponatremia in patients with aneurysmal sub arachnoid haemorrhage: a pilot study
Metro North Hospital and Health Service
40 participants
May 1, 2024
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- Age 18 years or older
- 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
- Admitted to an Intensive Care or High Dependency Unit
- Hospital admission for aneurysmal subarachnoid haemorrhage within 96 hours
Exclusion Criteria10
- Unable to receive enteral medications
- Pre-existing glucocorticoid or mineralocorticoid treatment (excluding inhaled)
- Previous allergic reaction to fludrocortisone
- Hospital admission for aSAH greater than 96 hours ago
- History of cardiac, hepatic or renal failure
- Hypernatraemia (Na>145mol/L) on the most recent blood sample at the time of screening.
- Death deemed imminent or inevitable
- Pregnancy (confirmed or suspected)
- Documented systemic fungal infection
- Previous enrolment in the trial
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Interventions
Fludrocortisone 100µg tablet six hourly for fourteen days.
Locations(3)
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ACTRN12622001551785