Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function
Information source: University of Turin, Italy
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis With Ascites
Intervention: hydrocortisone (Drug); dextrose solution 5% (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: University of Turin, Italy Official(s) and/or principal investigator(s):
Carlo Alessandria, MD, Principal Investigator, Affiliation: Division of gastroenterology and hepatology
Overall contact:
Carlo Alessandria, MD, Phone: 00390116335561, Email: carloalessandria@libero.it
Summary
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.
Clinical Details
Official title: Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics
Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: renal function
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Carlo Alessandria, MD, Phone: 00390116335561, Email: carloalessandria@libero.it
San Giovanni Battista Hospital, Turin 10126, Italy
Additional Information
Starting date: May 2008
Ending date: May 2009
Last updated: April 11, 2008
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