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

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Cortisol succinate; Fludrocortisone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

• Men between 20 and 30 years

• Body Mass Index between 18 kg/m² and 25 kg/m²

• Normal clinical examination

• Normal biological variables

• Normal electrocardiogram and echocardiography

• Written, voluntary informed consent

• Non smoker since at least a year

Non-inclusion Criteria:

• Any history of significant allergy

• Subjects with abnormal renal, pulmonary, cardiovascular, endocrine or hepatic function

• Medication during the study

• Alcohol consumption more than 30g/day or drug addiction

• Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.

• Exclusion period mentioned on the Healthy Volunteers National list

• Persons deprived of freedom or under guardianship