Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

Sponsor

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

Overall Status

Unknown status

CT.gov ID

NCT00562445

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Anticipated 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 1, 2007

Anticipated Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 Peptic bleeding
2 Portal hypertension bleeding
3 Severe acute pancreatitis

Outcome Measures

Primary Outcome Measures

Relative adrenal insufficiency [1 week]

Secondary Outcome Measures

Therapeutic failure [45 days]
Survival [45 days]
Variations in portal hypertension. [7 days]
Need for vasopressive drugs [45 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.