Liver cirrhosis with refractory ascites.
Conditions
Sponsors
The third department of internal medicine, Nara Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients over 20 years old 2)Patients obtained written informed consent 3) Life expectancy of at least 4 weeks 4) Adequate organ function a) Hb>= 8.0g/dL b) neutrophil: >= 1,500/mm3 c) Platelet: >= 30,000/mm3 d) Total bilirubin:< 4.0 mg/dL e) ALT and AST: <= within 6 folds of normal limit f) Serum creatine: <= 2.0 mg/dL g) Serum natrium: >= 120mEq/L
Exclusion criteria
Exclusion criteria: 1) Adequate cardiac organ function a) Patients with conjestive heart failure above NYHA class3 b) Patients with severe hypertension 2) Patients with severe and active infectious disease (exclude HBV,HCV hepatitis) 3) Patients with HIV 4) Patients taking dialysis 5) Patients with portal tumor thrombosis (Vp3 or Vp4) 6) Patients with hepatic encephalopathy 7) Patients with crutial digestive bleedings within 4 weeks 8) Patients with the following treatment a) Systemic chemotherapy b) Being treated with invasive surgical therapy within 4 weeks 9) Patients with oral intake difficulty 10)Patients with severe digestive diseases 11)Patients taking a tablet which would affect this clinical study 12)Pregnant woman, lactating woman, or a woman suspected of pregnancy 13)Patients with severe allergic reaction to Tolvaptan 14)Patients with drug abuse or psycological disorders 15) Patients concluded to be inappropriate to participate in this study by their physitians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of body weight. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of ascites. Increase of urine volume. Improvement of patient's symptom. | — |
Countries
Japan
Contacts
Public ContactHideto Kawaratani
Nara Medical University The third department of internal medicine
Outcome results
None listed