Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

• Conditions: Digestive Diseases; Adrenal Insufficiency; Gastrointestinal Bleeding; Variceal Bleeding; Acute Pancreatitis

• Registration Number: NCT00562445
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

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.

Study Timeline

• Study Start: 2007-05
• Status Verified: 2007-11
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Last Update Submitted: 2007-11-21
• Study First Posted: 2007-11-22
• Last Update Posted: 2007-11-22
• Study Completion: 2008-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

• Age <18 years and >80 years.
• Pregnancy.
• Patient refusal to participate in the study.
• Prior corticosteroids treatment(oral or topical).
• Treatment during the 30 days prior to inclusion with any of the following drugs: contraception, etomidate, ketoconazole, rifampin or phenytoin.
• History of cranial trauma or surgery.
• Any malignancy in treatment or progression.
• HIV infection.
• Prior known adrenal pathology.
• Patients not eligible to any active treatment because the existence of any clinical condition considered terminal.
• Patients with associated traumatic blood loss, or any other extraintestinal source of active bleeding.
• Burns.
• Patients who have been previously included in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative adrenal insufficiency	1 week

Secondary Outcome Measures

Name	Time	Method
Need for vasopressive drugs	45 days
Therapeutic failure	45 days
Survival	45 days
Variations in portal hypertension.	7 days

Trial Locations

Locations (1)

HospitalSCSP; 🇪🇸 Barcelona, Spain