Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function

Phase 2

• Conditions: Cirrhosis With Ascites
• Interventions: Drug: hydrocortisone; Drug: dextrose solution 5%

• Registration Number: NCT00657306
• Lead Sponsor: University of Turin, Italy

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-04
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-11
• Last Update Submitted: 2008-04-11
• Study First Posted: 2008-04-14
• Last Update Posted: 2008-04-14
• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	hydrocortisone	Hydrocortisone, 50 mg/6 h per day
2	dextrose solution 5%	dextrose solution 5%

Primary Outcome Measures

Name	Time	Method
renal function	10 days

Trial Locations

Locations (1)

San Giovanni Battista Hospital; 🇮🇹 Turin, Italy