Misra UK, et al. - Researchers performed this single-center, open-label, randomized clinical trial to test the safety as well as the efficacy of fludrocortisone in the treatment of cerebral salt wasting in patients with tuberculous meningitis. According to the findings obtained, fludrocortisone resulted in earlier normalization of serum sodium levels, however, did not affect results at 6 months. It was noted that fludrocortisone had to be withdrawn in 2 subjects as a result of severe adverse effects (hypokalemia and hypertension). In this analysis, class II evidence was provided on the role of fludrocortisone in treatment of hyponatremia related to cerebral salt wasting in patients with tuberculous meningitis.

Methods

• This trial conducted from October 2015 to April 2017 in India.
• Participants in the study were randomized in a 1:1 ratio 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.
• For at least 6 months, the patients were followed up.
• After that, study participants were randomized 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 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

• Ninety-three subjects with suspected tuberculous meningitis were enrolled.
• Twelve did not meet the inclusion criteria, including 4 with alternate diagnoses.
• Eligibility criteria involved 37 patients with cerebral salt wasting.
• One declined to partake, and therefore 36 subjects were involved, with 18 randomized to each group.
• It was observed that the median (range) age was 30 (20-46) years, and 19 were male (52.8%).
• It was noted that those receiving fludrocortisone regained normal serum sodium levels after 4 days, significantly earlier than those receiving saline only (15 days; P=.004).
• Findings revealed that in an intention-to-treat analysis, hospital mortality, disability at 3 months, and disability at 6 months did not vary significantly.
• Fewer infarcts occurred 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).
• Researchers found that fludrocortisone was related to severe hypokalemia and hypertension in 2 patients each, and pulmonary edema occurred in 1 patient and these adverse reactions necessitated discontinuation of fludrocortisone in 2 patients.