Fludrocortisone for adults with aneurysmal subarachnoid hemorrhage

A Prospective, Blinded, Randomised Clinical Trial of Fludrocortisone Compared With Placebo in Critically Ill Patients Presenting With Aneurysmal Subarachnoid Haemorrhage

This trial tests whether giving early enteral fludrocortisone to adults hospitalized with aneurysmal subarachnoid hemorrhage reduces death and long-term disability at six months.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 524 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The George Institute (other)
• Locations: 16 sites (New Lambton Heights, New South Wales and 15 other locations)
• Trial ID: NCT06409364 on ClinicalTrials.gov

What this trial studies

This is a multicentre, prospective, randomized, blinded, placebo-controlled Phase 2 trial comparing enteral fludrocortisone with placebo in adults with aneurysmal subarachnoid hemorrhage whose aneurysm has been secured. Participants are enrolled within 96 hours of hospital admission and receive the study drug while treated in a critical care environment, with outcomes including death and dependency at six months. Key exclusions include inability to receive enteral medication, pre-existing glucocorticoid or mineralocorticoid therapy, significant cardiac/hepatic/renal failure, abnormal sodium, pregnancy, or imminent death. The trial is being run at three tertiary hospitals in New South Wales, Australia.

Who should consider this trial

Good fit: Adults (≥18) with confirmed aneurysmal subarachnoid hemorrhage whose aneurysm has been secured, admitted to a participating ICU within 96 hours and able to receive enteral medication are ideal candidates.

Not a fit: Patients unable to receive enteral drugs, already on steroid/mineralocorticoid therapy, with severe cardiac/hepatic/renal failure, significant sodium abnormalities, pregnant, or with imminent death are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, it could reduce deaths and long-term disability after aSAH, improving patients' chances of returning to work and better quality of life.

How similar studies have performed: Use of fludrocortisone in aSAH is relatively novel with limited randomized data, though small studies and physiologic rationale support its potential to address salt-wasting and hemodynamic instability.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

New Lambton Heights, New South Wales and 15 other locations

• John Hunter Hospital — New Lambton Heights, New South Wales, Australia (NOT_YET_RECRUITING)
• Nepean Hospital — Penrith, New South Wales, Australia (RECRUITING)
• Prince of Wales Hospital — Randwick, New South Wales, Australia (NOT_YET_RECRUITING)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia (NOT_YET_RECRUITING)
• Westmead Hospital — Westmead, New South Wales, Australia (NOT_YET_RECRUITING)
• Wollongong Hospital — Wollongong, New South Wales, Australia (NOT_YET_RECRUITING)
• Royal Brisbane Women's Hospital — Brisbane, Queensland, Australia (NOT_YET_RECRUITING)
• Gold Coast University Hospital — Gold Coast, Queensland, Australia (RECRUITING)
• Townsville Hospital — Townsville, Queensland, Australia (NOT_YET_RECRUITING)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (NOT_YET_RECRUITING)
• Royal Hobart Hospital — Hobart, Tasmania, Australia (NOT_YET_RECRUITING)
• Monash Medical Centre — Clayton, Victoria, Australia (NOT_YET_RECRUITING)
• St Vincent's Hospital (Melbourne) — Fitzroy, Victoria, Australia (NOT_YET_RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (NOT_YET_RECRUITING)
• Auckland City Hospital — Auckland, New Zealand (NOT_YET_RECRUITING)
• Wellington Hospital — Wellington, New Zealand (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Jeremy Cohen, MBBS — Royal Brisbane Hospital, Brisbane, Australia
• Study coordinator: Jeremy Cohen, MBBS

Conditions: Aneurysmal Subarachnoid Hemorrhage, aSAH