Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

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

Status

Unknown

Conditions

Adrenal Insufficiency

Variceal Bleeding

Acute Pancreatitis

Gastrointestinal Bleeding

Digestive Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT00562445

ISRRA-HDA2007

EudraCT: 2007-002355-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and 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.