Misra UK, et al. - Researchers investigated the efficacy and safety of fludrocortisone vs saline in treating cerebral salt wasting with tuberculous meningitis. Outcomes of this randomized clinical trial suggest that earlier normalization of serum sodium could be achieved administering fludrocortisone in patients with cerebral salt wasting as a part of tuberculous meningitis.

Methods

• From October 2015 to April 2017, researchers performed a single-center, open-label, randomized clinical trial in India.
• In a 1:1 ratio, they randomized patients to arms receiving saline only or saline plus fludrocortisone, in addition to a standard treatment of 4 antitubercular drugs, prednisolone, and aspirin.
• For demographic, clinical, and magnetic resonance imaging findings, the 2 arms were matched.
• At least 6 months follow up of the patients was performed.
• They randomized the patients to a 0.9% solution of intravenous saline with 5 to 12 g per day of oral salt supplementation, with or without the addition of 0.1 to 0.4 mg of fludrocortisone per day.
• The time needed to correct serum sodium levels was assessed as the primary end point.
• In-hospital deaths, disability at 3 months, disability at 6 months, occurence of stroke, and serious adverse reactions were the secondary end points.

Results

• Researchers recruited 93 patients with suspected tuberculous meningitis; 12 did not meet the inclusion criteria, including 4 with alternate diagnoses.
• For this study, 37 patients with cerebral salt wasting met the eligibility criteria.
• On account of one refusal, 36 patients were included, with 18 randomized to each group.
• Patients had median (range) age of 30 (20-46) years, and 19 of them were male (52.8%).
• Normal serum sodium levels were achieved after 4 days among those receiving fludrocortisone, which was significantly earlier than those receiving saline only (15 days; P=.004).
• In an intention-to-treat analysis, they noted no significant differences in hospital mortality, disability at 3 months, and disability at 6 months, but a fewer infarcts in the deep border zone in the group receiving fludrocortisone (1 of 18 [6%]) vs those in the control arm (6 of 18 [33%]; P = .04).
• In 2 patients each, severe hypokalemia and hypertension, and in 1 patient, pulmonary edema occurred in association with fludrocortisone administration.
• Two patients discontinued fludrocortisone due to these adverse reactions.