| May 5, 2008 |
| July 30, 2009 |
| May 2008 |
| October 2008 (final data collection date for primary outcome measure) |
| Phenylephrine-mean arterial pressure dose-response relationship [ Time Frame: Between 1.5 and 3 hours after treatment ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00673270 on ClinicalTrials.gov Archive Site |
- Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: No ]
- Central aortic pressures, Augmentation Index (Aix) [ Time Frame: Between administration time and 12 hours after treatment ] [ Designated as safety issue: No ]
- Arterial stiffness: Carotid-femoral Pulse Wave Velocity [ Time Frame: Between administration time and 12 hours after treatment ] [ Designated as safety issue: No ]
- Humeral diameter and distensibility [ Time Frame: Between administration time and 12 hours after treatment ] [ Designated as safety issue: No ]
- Plasma electrolytes, blood glucose, serum creatinine [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: Yes ]
- Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: No ]
- Urinary electrolytes excretion [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression |
| 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. |
| |
| Phase I, Phase II |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Renin Angiotensin System |
- Drug: Fludrocortisone
- Drug: Hydrocortisone
- Drug: Placebo of Fludrocortisone
- Drug: Placebo of Hydrocortisone
|
- Experimental: Fludrocortisone and Hydrocortisone
- Experimental: Fludrocortisone and placebo of Hydrocortisone
- Experimental: Placebo of Fludrocortisone and Hydrocortisone
- Placebo Comparator: Placebo of Fludrocortisone and placebo of Hydrocortisone
|
| |
| |
| Completed |
| 12 |
| October 2008 |
| October 2008 (final data collection date for primary outcome measure) |
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.
Exclusion 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.
|
| Male |
| 20 Years to 30 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00673270 |
| Direction of Clinical Research and Strategy, Rennes University Hospital |
| EudraCT 2007-0077969-20, CIC0203/029 |
| Rennes University Hospital |
|
| Principal Investigator: |
Bruno LAVIOLLE, MD |
Rennes University Hospital |
|
| Study Chair: |
Eric BELLISSANT, MD, PhD |
Rennes University Hospital |
|
|
| Rennes University Hospital |
| July 2009 |