Fludrocortisone in Healthy Volunteers (AFLUCO4)

• Status: Completed
• Trial end date: 2016-04-20
• Target enrollment: 0
• Participant gender: Male

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.

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

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Fludrocortisone

Criteria

Inclusion Criteria:

• Men aged 20 to 25 years

• Body Mass Index between 20 kg/m² and 25 kg/m²

• Nonsmoker since at least 6 months

• Normal clinical examination, electrocardiogram and transthoracic echocardiography

• Normal routine biological parameters

• Written informed consent

Exclusion Criteria:

• History of significant allergy

• Resting heart rate < 50 bpm

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

• Ongoing medication during the study

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

• Exclusion period mentioned on the national registry for clinical trials volunteers.

• Subject under legal protection