Adrenal Insufficiency in Critical Emergencies in Digestive Diseases
|ClinicalTrials.gov Identifier: NCT00562445|
Recruitment Status : Unknown
Verified November 2007 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was: Recruiting
First Posted : November 22, 2007
Last Update Posted : November 22, 2007
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.
|Condition or disease|
|Digestive Diseases Adrenal Insufficiency Gastrointestinal Bleeding Variceal Bleeding Acute Pancreatitis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis)|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||May 2008|
U.S. FDA Resources
Portal hypertension bleeding
Severe acute pancreatitis
- Relative adrenal insufficiency [ Time Frame: 1 week ]
- Therapeutic failure [ Time Frame: 45 days ]
- Survival [ Time Frame: 45 days ]
- Variations in portal hypertension. [ Time Frame: 7 days ]
- Need for vasopressive drugs [ Time Frame: 45 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562445
|Contact: Candid Villanueva, MDfirstname.lastname@example.org|
|Barcelona, Spain, 08025|
|Contact: Candid Villanueva, MD +34620955006 email@example.com|
|Principal Investigator:||Candid Villanueva, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|