Fludrocortisone treatment in patients with aneurysmal sub arachnoid haemorrhage

Phase 2

• Conditions: Aneurysmal sub arachnoid haemorrhage; Neurological - Other neurological disorders; Stroke - Haemorrhagic

• Registration Number: ACTRN12622001551785
• Lead Sponsor: Metro North Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-15
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Age 18 years or older
2.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
3.Admitted to an Intensive Care or High Dependency Unit
4.Hospital admission for aneurysmal subarachnoid haemorrhage within 96 hours

Exclusion Criteria

1.Unable to receive enteral medications
2.Pre-existing glucocorticoid or mineralocorticoid treatment (excluding inhaled)
3.Previous allergic reaction to fludrocortisone
4.Hospital admission for aSAH greater than 96 hours ago
5.History of cardiac, hepatic or renal failure
6.Hypernatraemia (Na>145mol/L) on the most recent blood sample at the time of screening.
7.Death deemed imminent or inevitable
8.Pregnancy (confirmed or suspected)
9.Documented systemic fungal infection
10.Previous enrolment in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum sodium concentrations<br>[ Fourteen days post enrolment]

Secondary Outcome Measures

Name	Time	Method
Incidence of hyponatremia (defined as two consecutive serum sodium concentrations below 135mmol/L at least six hours apart)<br>[ During ICU admission]