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Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

Information source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Digestive Diseases; Adrenal Insufficiency; Gastrointestinal Bleeding; Variceal Bleeding; Acute Pancreatitis

Phase: N/A

Status: Recruiting

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

Official(s) and/or principal investigator(s):
Candid Villanueva, MD, Principal Investigator, Affiliation: FundaciĆ³ Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Overall contact:
Candid Villanueva, MD, Phone: +34620955006, Email: cvillanueva@santpau.es

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.

Clinical Details

Official title: Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis)

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Relative adrenal insufficiency

Secondary outcome:

Therapeutic failure

Survival

Variations in portal hypertension.

Need for vasopressive drugs

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria (one of the following):

- 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.

Locations and Contacts

Candid Villanueva, MD, Phone: +34620955006, Email: cvillanueva@santpau.es

HospitalSCSP, Barcelona 08025, Spain; Recruiting
Candid Villanueva, MD, Phone: +34620955006, Email: cvillanueva@sanrpau.es
Additional Information

Starting date: May 2007
Last updated: November 21, 2007

Page last updated: August 20, 2015

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