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

University of Turin

Status and phase: Unknown; Phase 2

Conditions: Cirrhosis With Ascites

Treatments: Drug: dextrose solution 5%; Drug: hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00657306

AILD

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Hydrocortisone, 50 mg/6 h per day

Treatment:

Drug: hydrocortisone

2

Placebo Comparator group

Description:

dextrose solution 5%

Treatment:

Drug: dextrose solution 5%