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Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

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ClinicalTrials.gov Identifier: NCT00562445
Recruitment Status : Unknown
Verified November 2007 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : November 22, 2007
Last Update Posted : November 22, 2007
Information provided by:

Study Description
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.

Condition or disease
Digestive Diseases Adrenal Insufficiency Gastrointestinal Bleeding Variceal Bleeding 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.

Study Design

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis)
Study Start Date : May 2007
Estimated Study Completion Date : May 2008

Groups and Cohorts

Peptic bleeding
Portal hypertension bleeding
Severe acute pancreatitis

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562445

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

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

ClinicalTrials.gov Identifier: NCT00562445     History of Changes
Other Study ID Numbers: ISRRA-HDA2007
EudraCT: 2007-002355-16
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: November 2007

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
Severe acute pancreatitis

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Adrenal Insufficiency
Digestive System Diseases
Gastrointestinal Diseases
Disease Attributes
Pathologic Processes
Pancreatic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents