NCT00673270

Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression

Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 30 Years
• Healthy volunteers: Accepted

Summary

Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.

Conditions

• Renin Angiotensin

Interventions

Type	Name	Description
DRUG	Fludrocortisone	50 µg of fludrocortisone per os
DRUG	Hydrocortisone	50 mg of intravenous hydrocortisone
DRUG	Placebo of Fludrocortisone	Tablet of placebo of Fludrocortisone
DRUG	Placebo of Hydrocortisone	2 ml of isotonic saline solution

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-10-01
• Completion: 2009-03-01
• First posted: 2008-05-07
• Last updated: 2012-03-02

Locations

1 site across 1 country: France