Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Candid Villanueva, MD; Phone Number: +34620955006; Email: cvillanueva@santpau.es

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to our centre that meet inclusion criteria and do not meet exclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
1; Peptic bleeding
2; Portal hypertension bleeding
3; Severe acute pancreatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative adrenal insufficiency	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Therapeutic failure	45 days
Survival	45 days
Variations in portal hypertension.	7 days
Need for vasopressive drugs	45 days

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Candid Villanueva, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Study Completion (Anticipated): May 1, 2008

Study Registration Dates

• First Submitted: November 21, 2007
• First Submitted That Met QC Criteria: November 21, 2007
• First Posted (Estimate): November 22, 2007

Study Record Updates

• Last Update Posted (Estimate): November 22, 2007
• Last Update Submitted That Met QC Criteria: November 21, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: GI bleeding; Portal hypertension; Acute pancreatitis; Adrenal insufficiency; Severe acute pancreatitis; Critical emergencies in digestive diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease Attributes; Pancreatic Diseases; Adrenal Gland Diseases; Emergencies; Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Pancreatitis; Gastrointestinal Hemorrhage; Adrenal Insufficiency
• Other Study ID Numbers: ISRRA-HDA2007; EudraCT: 2007-002355-16