Purpose

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.


Condition
Digestive Diseases
Adrenal Insufficiency
Gastrointestinal Bleeding
Variceal Bleeding
Acute Pancreatitis

Genetics Home Reference related topics:   Digestive Diseases  

MedlinePlus related topics:   Digestive Diseases   Gastrointestinal Bleeding   High Blood Pressure  

ChemIDplus related topics:   Epinephrine   Epinephrine bitartrate  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis)

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Relative adrenal insufficiency [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Therapeutic failure [ Time Frame: 45 days ]
  • Survival [ Time Frame: 45 days ]
  • Variations in portal hypertension. [ Time Frame: 7 days ]
  • Need for vasopressive drugs [ Time Frame: 45 days ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   75
Study Start Date:   May 2007
Estimated Study Completion Date:   May 2008

Groups/Cohorts
1
Peptic bleeding
2
Portal hypertension bleeding
3
Severe acute pancreatitis

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
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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


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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562445

Contacts
Contact: Candid Villanueva, MD     34620955006     cvillanueva@santpau.es    

Locations
Spain
HospitalSCSP     Recruiting
      Barcelona, Spain, 08025
      Contact: Candid Villanueva, MD     34620955006     cvillanueva@sanrpau.es    

Sponsors and Collaborators
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    
Contact: Candid Villanueva, MD     34620955006     cvillanueva@santpau.es    
Spain
HospitalSCSP     Recruiting
      Barcelona, Spain, 08025
      Contact: Candid Villanueva, MD     34620955006     cvillanueva@sanrpau.es    
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator:     Candid Villanueva, MD     Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau    
  More Information

Study ID Numbers:   ISRRA-HDA2007, EudraCT: 2007-002355-16
First Received:   November 21, 2007
Last Updated:   November 21, 2007
ClinicalTrials.gov Identifier:   NCT00562445
Health Authority:   Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Adrenal insufficiency  
GI bleeding  
Portal hypertension  
Acute pancreatitis  
Critical emergencies in digestive diseases
GI bleeding
Severe acute pancreatitis

Study placed in the following topic categories:
Adrenal Insufficiency
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Adrenal Gland Diseases
Hypertension, Portal
Hemorrhage
Hypoadrenalism
Portal hypertension
Adrenal gland hypofunction
Emergencies
Pancreatic Diseases
Endocrinopathy
Epinephrine
Pancreatitis
Hypertension

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Digestive System Diseases
Gastrointestinal Hemorrhage
Endocrine System Diseases

Source: National Library of Medicine (NLM) July 03, 2008