Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression (AFLUCO2)

Rennes University Hospital

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Renin Angiotensin

Treatments: Drug: Hydrocortisone; Drug: Fludrocortisone; Drug: Placebo of Fludrocortisone; Drug: Placebo of Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00673270

EudraCT 2007-0077969-20

CIC0203/029

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Male

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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13 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Fludrocortisone and Hydrocortisone

Treatment:

Drug: Fludrocortisone

Drug: Hydrocortisone

2

Experimental group

Description:

Fludrocortisone and placebo of Hydrocortisone

Treatment:

Drug: Fludrocortisone

Drug: Placebo of Hydrocortisone

3

Experimental group

Description:

Placebo of Fludrocortisone and Hydrocortisone

Treatment:

Drug: Placebo of Fludrocortisone

Drug: Hydrocortisone

4

Placebo Comparator group

Description:

Placebo of Fludrocortisone and placebo of Hydrocortisone

Treatment:

Drug: Placebo of Fludrocortisone

Drug: Placebo of Hydrocortisone