Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIC0203/029 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fludrocortisone and Hydrocortisone |
|
| 2 | Experimental | Fludrocortisone and placebo of Hydrocortisone |
|
| 3 | Experimental | Placebo of Fludrocortisone and Hydrocortisone |
|
| 4 | Placebo Comparator | Placebo of Fludrocortisone and placebo of Hydrocortisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludrocortisone | Drug | 50 µg of fludrocortisone per os |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phenylephrine-mean arterial pressure dose-response relationship | Between 1.5 and 3 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances | Between administration time and 24 hours after treatment | |
| Central aortic pressures, Augmentation Index (Aix) | Between administration time and 12 hours after treatment |
Not provided
Inclusion Criteria:
Non-inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruno LAVIOLLE, MD | Rennes University Hospital | Principal Investigator |
| Eric BELLISSANT, MD, PhD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité d'Investigation Clinique - Hôpital de Pontchaillou | Rennes | 35033 | France |
Not provided
| ID | Term |
|---|---|
| D005438 | Fludrocortisone |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hydrocortisone |
| Drug |
50 mg of intravenous hydrocortisone |
|
| Placebo of Fludrocortisone | Drug | Tablet of placebo of Fludrocortisone |
|
| Placebo of Hydrocortisone | Drug | 2 ml of isotonic saline solution |
|
| Arterial stiffness: Carotid-femoral Pulse Wave Velocity | Between administration time and 12 hours after treatment |
| Humeral diameter and distensibility | Between administration time and 12 hours after treatment |
| Plasma electrolytes, blood glucose, serum creatinine | Between administration time and 24 hours after treatment |
| Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations | Between administration time and 24 hours after treatment |
| Urinary electrolytes excretion | Between administration time and 24 hours after treatment |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |