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

Cirrhosis With Ascites Clinical Trial

— AILD  

Official title:

Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00657306
• Other study ID #: AILD
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 9, 2008
• Last updated: April 11, 2008
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2008
• Source: University of Turin, Italy
• Contact: Carlo Alessandria, MD
• Phone: 00390116335561
• Email: carloalessandria[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Ascites
• Cirrhosis With Ascites

Intervention

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

Locations

Country	Name	City	State
Italy	San Giovanni Battista Hospital	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function		10 days	No