FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

Launched by THE GEORGE INSTITUTE · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called fludrocortisone in patients who have experienced an aneurysmal subarachnoid hemorrhage, which is a type of bleeding in the brain caused by a burst blood vessel. The goal of the study is to find out if giving this medication early can help reduce the chances of death and long-term dependence on others for daily activities after six months. The trial will compare fludrocortisone with a placebo, which is a harmless substance that looks like the medication but has no active ingredients.

To participate in this trial, individuals must be at least 18 years old, have been diagnosed with subarachnoid hemorrhage confirmed by specific imaging tests, and must currently be in a critical care setting. They should have received treatment to secure the aneurysm within 96 hours of admission. However, those who cannot take oral medications, have certain pre-existing health conditions, or are pregnant are not eligible. If someone joins the trial, they will be randomly assigned to receive either the fludrocortisone or the placebo and will be monitored closely for their health outcomes over the next six months.

Gender

ALL

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