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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renin Angiotensin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Fludrocortisone and Hydrocortisone

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

50 µg of fludrocortisone per os

Hydrocortisone

Intervention Type DRUG

50 mg of intravenous hydrocortisone

2

Fludrocortisone and placebo of Hydrocortisone

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

50 µg of fludrocortisone per os

Placebo of Hydrocortisone

Intervention Type DRUG

2 ml of isotonic saline solution

3

Placebo of Fludrocortisone and Hydrocortisone

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

50 mg of intravenous hydrocortisone

Placebo of Fludrocortisone

Intervention Type DRUG

Tablet of placebo of Fludrocortisone

4

Placebo of Fludrocortisone and placebo of Hydrocortisone

Group Type PLACEBO_COMPARATOR

Placebo of Fludrocortisone

Intervention Type DRUG

Tablet of placebo of Fludrocortisone

Placebo of Hydrocortisone

Intervention Type DRUG

2 ml of isotonic saline solution

Interventions

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Fludrocortisone

50 µg of fludrocortisone per os

Intervention Type DRUG

Hydrocortisone

50 mg of intravenous hydrocortisone

Intervention Type DRUG

Placebo of Fludrocortisone

Tablet of placebo of Fludrocortisone

Intervention Type DRUG

Placebo of Hydrocortisone

2 ml of isotonic saline solution

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes