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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2007-002355-16 |
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Observational study about the incidence of relative adrenal insufficiency in patients with cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal bleeding and without liver disease; and in patients with severe acute pancreatitis.
This is a study using pharmaceutical specialties in the approved conditions of use.
Observational, prospective, open-label, in-patient study, that includes patients with upper gastrointestinal bleeding of variceal or peptic origin, and in patients with severe acute pancreatitis.
The adrenal function of every patient included will be evaluated in the first 24 hours of admission This assessment shall be performed using the corticotropin-stimulation short test (synacthen test), that includes serum and saliva determination of cortisol, in basal conditions and 30 and 60 minutes after the administration of 250 ug of corticotropin synthetic (Synacthen, Novartis Pharma AG, Basel, Switzerland).
The cortisol levels will be determined by competitive immunoassay using direct chemoluminescence technology (Bayer Corporation, Pittsburgh, PA, USA).
In patients with severe acute pancreatitis all of these determinations will be repeated at the third day of admission.
Several other clinical and biochemical features will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Peptic bleeding | ||
| 2 | Portal hypertension bleeding | ||
| 3 | Severe acute pancreatitis |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative adrenal insufficiency | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic failure | 45 days | |
| Survival | 45 days | |
| Variations in portal hypertension. |
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Inclusion Criteria (one of the following):
Exclusion Criteria:
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Patients admitted to our centre that meet inclusion criteria and do not meet exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Candid Villanueva, MD | Contact | +34620955006 | cvillanueva@santpau.es |
| Name | Affiliation | Role |
|---|---|---|
| Candid Villanueva, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HospitalSCSP | Recruiting | Barcelona | Barcelona | 08025 | Spain |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D000309 | Adrenal Insufficiency |
| D006471 | Gastrointestinal Hemorrhage |
| D010195 | Pancreatitis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D005767 | Gastrointestinal Diseases |
| D006470 | Hemorrhage |
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| 7 days |
| Need for vasopressive drugs | 45 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D008107 | Liver Diseases |