Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

NCT00562445 | Unknown DMC

• 2 other identifiers: ISRRA-HDA2007EudraCT: 2007-002355-16
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Relative adrenal insufficiency

  1 week

Secondary Outcomes (4)

• Therapeutic failure

  45 days

• Survival

  45 days

• Variations in portal hypertension.

  7 days

• Need for vasopressive drugs

  45 days

Study Arms (3)

1

Peptic bleeding

2

Portal hypertension bleeding

3

Severe acute pancreatitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Age \<18 years and \>80 years.
• Pregnancy.
• Patient refusal to participate in the study.
• Prior corticosteroids treatment(oral or topical).
• 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.

Sponsors & Collaborators

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

Study Sites (1)

HospitalSCSP

Barcelona, Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases; Adrenal Insufficiency; Gastrointestinal Hemorrhage; Pancreatitis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Liver Diseases

Study Officials

• Candid Villanueva, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candid Villanueva, MD

CONTACT

+34620955006; cvillanueva@santpau.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 22, 2007
• Study Start: May 1, 2007
• Study Completion: May 1, 2008
• Last Updated: November 22, 2007

Record last verified: 2007-11

Locations

ES (1)