Randomized Trial of Fludrocortisone Versus Placebo for Treatment in Adults With Aneurysmal Subarachnoid Hemorrhage in Critical Care

What this Trial Is About

This research aims to evaluate whether early use of enteral fludrocortisone can reduce death and dependency six months after aneurysmal subarachnoid haemorrhage aSAH, a severe type of stroke that mainly affects adults aged 45 to 64 and more often women. The condition has a high mortality rate and many survivors face lasting neurological and cognitive problems, impacting their quality of life and ability to work. The study will address the need for better treatment options given the high healthcare costs and poor outcomes associated with aSAH. Participants will be randomly assigned to receive either fludrocortisone or a matched placebo tablet every six hours by mouth for 14 days. Fludrocortisone is a synthetic steroid that helps retain sodium and fluids, potentially preventing hyponatraemia, a common and serious complication of aSAH that can worsen brain swelling and increase the risk of further brain injury. This trial is blinded and controlled to compare the effects of fludrocortisone against placebo in critically ill patients. During the study, participants will be monitored in a critical care setting with regular assessments including neurological evaluations and laboratory tests. The main outcome measured will be the level of disability or recovery at six months using the Modified Rankin Scale. Additional assessments will include quality of life tools specific to subarachnoid haemorrhage. Safety and side effects will be closely observed throughout the study. The total duration of participation includes treatment and follow-up assessments up to six months after randomization.

FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage