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Adrenal Insufficiency in Critical Emergencies in Digestive Diseases
This study is currently recruiting participants.
Study NCT00562445   Information provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First Received: November 21, 2007   No Changes Posted

November 21, 2007
November 21, 2007
May 2007
 
Relative adrenal insufficiency [ Time Frame: 1 week ]
Same as current
No Changes Posted
  • 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 ]
Same as current
 
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.

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.

 
Observational
Case-Only, Prospective
  • Digestive Diseases
  • Adrenal Insufficiency
  • Gastrointestinal Bleeding
  • Variceal Bleeding
  • Acute Pancreatitis
 
  • Peptic bleeding
  • Portal hypertension bleeding
  • Severe acute pancreatitis
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
75
May 2008
 

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.
Both
18 Years to 80 Years
No
Contact: Candid Villanueva, MD +34620955006 cvillanueva@santpau.es
Spain
 
NCT00562445
 
ISRRA-HDA2007, EudraCT: 2007-002355-16
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
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP