Healthy Volunteers Clinical Trial
Official title:
Hemodynamic and Biological Effects of 3 Increasing Doses of Fludrocortisone in Healthy Volunteers
Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in
survival in septic shock patients with relative adrenal insufficiency. However, the utility
of low doses of steroids and in particular of mineralocorticoids in septic shock is still
discussed.
The purpose of the investigators study is to investigate the effects of 3 increasing doses of
fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best
pressor response to phenylephrine in healthy volunteers, and simultaneously assess their
respective hemodynamic and biological effects.
In a previous study (AFLUCO2) in healthy volunteers with saline-induced hypoaldosteronism,
the investigators found that single doses of both hydrocortisone and fludrocortisone induced
a significant decrease in the pressor response to phenylephrine, probably due to a rapid
non-genomic vasodilatory mechanism, and that these effects were additive.
The investigators also showed that, at the doses used in septic shock, hydrocortisone induced
more pronounced mineralocorticoid effects than fludrocortisone and also induced systemic
hemodynamic effects whereas fludrocortisone did not.
The investigators now want to perform a dose-response study under normal conditions (ie
without saline-induced hypoaldosteronism) and after repeated administrations, to determine
the optimal dose of fludrocortisone that allows an increase in the pressor response to
phenylephrine and to characterize its concomitant hemodynamic and biological effects.
This placebo-controlled, randomized, double-blind, cross-over, 4-periods (fludrocortisone 100
μg/day, 200 μg/day, 400 μg/day, or placebo) study aims to investigate hemodynamic and
biological effects of fludrocortisone administered orally during 5 days, in healthy
volunteers.
Each period will be separated from the next one by a washout interval of at least 14 days.
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