NCT02140918

Fludrocortisone in Healthy Volunteers (AFLUCO4)

Hemodynamic and Biological Effects of 3 Increasing Doses of Fludrocortisone in Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Fludrocortisone 100 μg	Fludrocortisone 100 μg/day
DRUG	Fludrocortisone 200 μg	Fludrocortisone 200 μg/day
DRUG	Fludrocortisone 400 μg	Fludrocortisone 400 μg/day
DRUG	Placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-04-20
• Completion: 2016-04-20
• First posted: 2014-05-16
• Last updated: 2018-08-29

Locations

1 site across 1 country: France