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| ID | Type | Description | Link |
|---|---|---|---|
| CIC0203/082 |
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Problems of drugs supply by the manufacturer
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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 alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fludrocortisone |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludrocortisone | Drug | 50 µg of fludrocortisone per os |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Norepinephrine-mean arterial pressure dose-response relationship | 1.5 h after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances | During 3 h after administration | |
| Central aortic pressures, Augmentation Index (Aix). | During 3 h after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Service de Réanimation Chirurgicale - Hôpital de Pontchaillou | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D005438 | Fludrocortisone |
| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
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| Placebo | Drug | 1 tablet of placebo per os |
|
| Arterial stiffness: Carotid-femoral Pulse Wave Velocity | During 3 h after administration |
| Humeral diameter and distensibility | During 3 h after administration |
| Gastric mucosal perfusion | During 3 h after administration |
| Plasma electrolytes, blood glucose, serum creatinine | Each hour during 3 h after administration |
| Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations | Each hour during 3 h after administration |
| Urinary electrolytes excretion | Each hour during 3 h after administration |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |