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| Tracking Information | |||||
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| First Received Date ICMJE | November 21, 2007 | ||||
| Last Updated Date | November 21, 2007 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Relative adrenal insufficiency [ Time Frame: 1 week ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Adrenal Insufficiency in Critical Emergencies in Digestive Diseases | ||||
| Official Title ICMJE | Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis) | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | May 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria (one of the following):
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00562445 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | ISRRA-HDA2007, EudraCT: 2007-002355-16 | ||||
| Study Sponsor ICMJE | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||
| Verification Date | November 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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