Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00562445
• Other study ID #: ISRRA-HDA2007
• Secondary ID: EudraCT: 2007-00
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2007
• Last updated: November 21, 2007
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2007
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Candid Villanueva, MD
• Phone: +34620955006
• Email: cvillanueva[@]santpau.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pancreatitis
• Adrenal Insufficiency
• Digestive Diseases
• Digestive System Diseases
• Emergencies
• Gastrointestinal Bleeding
• Gastrointestinal Diseases
• Gastrointestinal Hemorrhage
• Hemorrhage
• Pancreatitis
• Variceal Bleeding

Locations

Country	Name	City	State
Spain	HospitalSCSP	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative adrenal insufficiency		1 week
Secondary	Therapeutic failure		45 days
Secondary	Survival		45 days
Secondary	Variations in portal hypertension.		7 days
Secondary	Need for vasopressive drugs		45 days