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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.
U.S. FDA Resources
Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: Primary Outcome Measures:
Secondary Outcome Measures:
Biospecimen Retention: None Retained Biospecimen Description:
Detailed Description: 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. Eligibility
Study Population Patients admitted to our centre that meet inclusion criteria and do not meet exclusion criteria Criteria Inclusion Criteria (one of the following):
Exclusion Criteria:
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00562445 Contacts
Locations
Sponsors and Collaborators
Investigators
More Information
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Study placed in the following topic categories:
Additional relevant MeSH terms:
Source: National Library of Medicine (NLM) July 03, 2008 |
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