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

Phase 2TerminatedNCT00673270

Rennes University Hospital13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Renin Angiotensin

Interventions

Eligibility

Sex: MALEMin age: 20 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Phenylephrine-mean arterial pressure dose-response relationship

Time frame: Between 1.5 and 3 hours after treatment

Secondary Outcomes

Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances

Time frame: Between administration time and 24 hours after treatment

Central aortic pressures, Augmentation Index (Aix)

Time frame: Between administration time and 12 hours after treatment

Arterial stiffness: Carotid-femoral Pulse Wave Velocity

Time frame: Between administration time and 12 hours after treatment

Humeral diameter and distensibility

Time frame: Between administration time and 12 hours after treatment

Plasma electrolytes, blood glucose, serum creatinine

Time frame: Between administration time and 24 hours after treatment

Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations

Time frame: Between administration time and 24 hours after treatment

Urinary electrolytes excretion

Time frame: Between administration time and 24 hours after treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes