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Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00562445
First received: November 21, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562445     History of Changes
Other Study ID Numbers: ISRRA-HDA2007, EudraCT: 2007-002355-16
Study First Received: November 21, 2007
Last Updated: November 21, 2007
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
Severe acute pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Autoimmune Diseases
Adrenal Insufficiency
Addison Disease
Digestive System Diseases
Gastrointestinal Diseases
Emergencies
Gastrointestinal Hemorrhage
 Hemorrhage
Adrenal Gland Diseases
Endocrine System Diseases
Immune System Diseases
Disease Attributes
Pathologic Processes
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013