cirrhosis and ascites MedDRA version: 12.0 Level: LLT Classification code 10019846 Term: Hepatorenal syndrome
Conditions
Interventions
Trade Name: SOLUCORTEF*1FL 100MG/2ML 2ML
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Hydrocortisone
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 75
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed