RecruitingPhase 2NCT06409364

FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

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


Sponsor

The George Institute

Enrollment

524 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Interventions

DRUGFludrocortisone

small white tablet containing 100mcg of fludrocortsone

DRUGPlacebo

Matched placebo tablet,


Locations(16)

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Nepean Hospital

Penrith, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Royal Brisbane Women's Hospital

Brisbane, Queensland, Australia

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Townsville Hospital

Townsville, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Monash Medical Centre

Clayton, Victoria, Australia

St Vincent's Hospital (Melbourne)

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Auckland City Hospital

Auckland, New Zealand

Wellington Hospital

Wellington, New Zealand

View Full Details on ClinicalTrials.gov

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NCT06409364


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