A Study on predictors of treatment response concerning of the efficacy of tolvaptan on refractory ascites.
- Conditions
- iver cirrhosis with refractory ascites.
- Registration Number
- JPRN-UMIN000026426
- Lead Sponsor
- The third department of internal medicine, Nara Medical University
- Brief Summary
ot available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
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 psychological disorders 15) Patients concluded to be inappropriate to participate in this study by their physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Over 1.5kg decrease of body weight.
- Secondary Outcome Measures
Name Time Method Increase of urine volume. Improvement of physical symptom. Improvement of patient's symptom by using questionnaire (ASI-7 and CLD-Q).