Renin Angiotensin Clinical Trial
— AFLUCO2Official title:
Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression
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.
| Status | Terminated |
| Enrollment | 13 |
| Est. completion date | March 2009 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 20 Years to 30 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Unité d'Investigation Clinique - Hôpital de Pontchaillou | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Phenylephrine-mean arterial pressure dose-response relationship | Between 1.5 and 3 hours after treatment | No | |
| Secondary | Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances | Between administration time and 24 hours after treatment | No | |
| Secondary | Central aortic pressures, Augmentation Index (Aix) | Between administration time and 12 hours after treatment | No | |
| Secondary | Arterial stiffness: Carotid-femoral Pulse Wave Velocity | Between administration time and 12 hours after treatment | No | |
| Secondary | Humeral diameter and distensibility | Between administration time and 12 hours after treatment | No | |
| Secondary | Plasma electrolytes, blood glucose, serum creatinine | Between administration time and 24 hours after treatment | Yes | |
| Secondary | Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations | Between administration time and 24 hours after treatment | No | |
| Secondary | Urinary electrolytes excretion | Between administration time and 24 hours after treatment | No |