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Study 19 of 27 for search of: | "Adrenoleukodystrophy" |
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Sponsored by: |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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Information provided by: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT00562445 |
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 |
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Digestive Diseases Adrenal Insufficiency Gastrointestinal Bleeding Variceal Bleeding Acute Pancreatitis |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis) |
Estimated Enrollment: | 75 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2008 |
Groups/Cohorts |
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1
Peptic bleeding
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2
Portal hypertension bleeding
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3
Severe acute pancreatitis
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients admitted to our centre that meet inclusion criteria and do not meet exclusion criteria
Inclusion Criteria (one of the following):
Exclusion Criteria:
Contact: Candid Villanueva, MD | +34620955006 | cvillanueva@santpau.es |
Spain | |
HospitalSCSP | Recruiting |
Barcelona, Spain, 08025 | |
Contact: Candid Villanueva, MD +34620955006 cvillanueva@sanrpau.es |
Principal Investigator: | Candid Villanueva, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Study ID Numbers: | ISRRA-HDA2007, EudraCT: 2007-002355-16 |
Study First Received: | November 21, 2007 |
Last Updated: | November 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00562445 |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
Adrenal insufficiency GI bleeding Portal hypertension Acute pancreatitis |
Critical emergencies in digestive diseases GI bleeding Severe acute pancreatitis |
Addison's disease Adrenal Insufficiency Autoimmune Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Adrenal Gland Diseases Endocrine System Diseases Hypertension, Portal Hypoadrenalism Hemorrhage Portal hypertension |
Adrenal gland hypofunction Digestive System Diseases Adrenoleukodystrophy Addison Disease Pancreatic Diseases Emergencies Endocrinopathy Epinephrine X-linked adrenoleukodystrophy Pancreatitis Hypertension |
Disease Attributes Pathologic Processes Immune System Diseases |