Fludrocortisone administration in aneurysmal subarachnoid haemorrhage (NCT06409364)

A multi-centre, prospective, blinded, randomised clinical trial of fludrocortisone compared with placebo in patients presenting with aneurysmal subarachnoid haemorrhage.

The study aim is to determine if early administration of enteral fludrocortisone in aneurysmal subarachnoid haemorrhage reduce death and dependency at six months.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Professor Andrew Udy

Key inclusion data

Inclusion Criteria: Age 18 years or older; Diagnosed with subarachnoid haemorrhage from an aneurysm confirmed on computed tomography angiography (CTA) or digital subtraction angiography (DSA) of the intra-cranial arteries; Aneurysm has been secured; Hospital admission for aSAH within 96 hours; Currently being treated in a critical care environment.

Exclusion Criteria: Unable to receive enteral medications; Pre-existing glucocorticoid or mineralocorticoid treatment; Previous allergic reaction to fludrocortisone; History of cardiac, hepatic, or renal failure; Hypernatremia or hyponatremia (Na>145mmol/L or Na<125mmol/L) on the most recent blood sample at the time of screening; Death deemed imminent or inevitable; Pregnancy (confirmed or suspected); Previous inclusion in the FLASH trial.