Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
- 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%
Outcome Measures for this Clinical Trial
Primary Measures
- renal function
- Time Frame: 10 days
Safety Issue?: No
- Time Frame: 10 days
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: University of Turin, Italy Other
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
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00657306
