WithdrawnPhase 2ACTRN12622001551785

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


Sponsor

Metro North Hospital and Health Service

Enrollment

40 participants

Start Date

May 1, 2024

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

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.

Fludrocortisone 100µg tablet six hourly for fourteen days.


Locations(3)

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,VIC, Australia

The Alfred - Melbourne

NSW,QLD,VIC, Australia

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ACTRN12622001551785