Clinical trial NCT00673270: Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression
Official title: Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Renin Angiotensin
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 13
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Phenylephrine-mean arterial pressure dose-response relationship
timeFrame: Between 1.5 and 3 hours after treatment
Secondary outcomes:
measure: Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
timeFrame: Between administration time and 24 hours after treatment
measure: Central aortic pressures, Augmentation Index (Aix)
timeFrame: Between administration time and 12 hours after treatment
measure: Arterial stiffness: Carotid-femoral Pulse Wave Velocity
timeFrame: Between administration time and 12 hours after treatment
measure: Humeral diameter and distensibility
timeFrame: Between administration time and 12 hours after treatment
measure: Plasma electrolytes, blood glucose, serum creatinine
timeFrame: Between administration time and 24 hours after treatment
measure: Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations
timeFrame: Between administration time and 24 hours after treatment
measure: Urinary electrolytes excretion
timeFrame: Between administration time and 24 hours after treatment
Other outcomes:
Locations:
city: Rennes
country: France
facility: Unité d'Investigation Clinique - Hôpital de Pontchaillou
Study officials:
affiliation: Rennes University Hospital
name: Bruno LAVIOLLE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Eric BELLISSANT, MD, PhD
role: STUDY_CHAIR
References: