Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

NCT ID: NCT00562445

Last Updated: 2007-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-05-31

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.

Conditions

Digestive Diseases; Adrenal Insufficiency; Gastrointestinal Bleeding; Variceal Bleeding; Acute Pancreatitis

Keywords

Adrenal insufficiency; GI bleeding; Portal hypertension; Acute pancreatitis; Critical emergencies in digestive diseases; Severe acute pancreatitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Peptic bleeding

No interventions assigned to this group

2

Portal hypertension bleeding

No interventions assigned to this group

3

Severe acute pancreatitis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Presence of acute upper gastrointestinal bleeding (variceal or peptic) + presence of hypovolemic shock (defined as a systolic blood pressure <100 mmHg coupled with a heart rate> 100 ppm), or Hb < 80 g / L;
• Acute pancreatitis (diagnosed by clinical, radiological and biochemical features)with severity criteria (At least one of the following: index of Ranson > 3, APACHE II > 8 or CPR> 120 mg/L, Balthazar CT grade E)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Principal Investigators

Candid Villanueva, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

HospitalSCSP

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Candid Villanueva, MD

Role: CONTACT

Phone: +34620955006

Email: cvillanueva@santpau.es

Facility Contacts

Candid Villanueva, MD

Role: primary

Other Identifiers

EudraCT: 2007-002355-16

Identifier Type: -

Identifier Source: secondary_id

ISRRA-HDA2007

Identifier Type: -

Identifier Source: org_study_id