Relative adrenal insufficiency in cirrhosis: relevance in patients with ascites and treatment with hydrocortisone in refractory ascites - ND
- Conditions
- cirrhosis and ascitesMedDRA version: 12.0Level: LLTClassification code 10019846Term: Hepatorenal syndrome
- Registration Number
- EUCTR2009-011531-13-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with cirrhosis and ascites, refractory ascites, hepatorenal syndrome
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.without shock and/or bacterial infection 2.active bleeding 3.ongoing vasoactive or steroid drugs 4.multifocal HCC 5.organic renal failure 6.hearth or pulmonary failure 7. age < 18 or > 75
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: - the impact of treatment with hydrocortisone in patients with relative adrenal insufficiency and refractory ascites/hepatorenal syndrome (PART TWO);Primary end point(s): Emonstrate that relative adrenal insufficiency is common in cirrhotic patients without sepsis and refractory ascites/ hepatorenal syndrome; hydrocortisone, by improving circulatory and renal function, could represent a novel therapeutic tool for refractory ascites;Main Objective: - the incidence of relative adrenal insufficiency among cirrhotic patients with ascites and without signs of clinical sepsis (PART ONE)
- Secondary Outcome Measures
Name Time Method