Official Title: “Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics”

Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines.

Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: hydrocortisone
  • 50 mg/6 h per day
• Drug: dextrose solution 5%
  • dextrose solution 5% 100 ml/6 h per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Hydrocortisone, 50 mg/6 h per day
• Placebo Comparator: 2
  • dextrose solution 5%

Primary Measures

• renal function
  • Time Frame: 10 days
    Safety Issue?: No

Inclusion Criteria:

• Cirrhosis with ascites, with or without hepatorenal syndrome

Exclusion Criteria:

• Age < 18 and > 75 years
• Shock or bacterial infection present at the inclusion or during the previous week
• Bleeding present at the inclusion or during the previous week
• Multifocal HCC
• Organic renal failure
• Hearth or pulmonary failure

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Turin, Italy

Overall Clinical Trial Officials and Contacts

Carlo Alessandria, MD Principal Investigator Division of gastroenterology and hepatology  

Overall Contact: Carlo Alessandria, MD 00390116335561 carloalessandria@libero.it

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00657306

Study ID Number: AILD

ClinicalTrials.gov Identifier: NCT00657306

Health Authority: Italy: National Institute of Health