drugset / Trial / NCT02140918

Fludrocortisone in Healthy Volunteers (AFLUCO4)

NCT02140918

Phase 2 Completed 16 enrolled Rennes University Hospital
RandomizedCrossoverQuadruple-blindBasic science

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.

Timeline

Start
2014-07-01
Primary completion
2016-04-20
Completion
2016-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludrocortisone Other / unclassified 100 ug Oral
Subject Fludrocortisone Other / unclassified 200 ug Oral
Subject Fludrocortisone Other / unclassified 400 ug Oral

Indications

No indication recorded.