Multicenter study of the effect of loop diuretics for liver function and kidney function for patients using tolvaptan

Multicenter study of the effect of loop diuretics for liver function and kidney function for patients using tolvaptan - The study of the effect of loop diuretics for patients using tolvaptan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033223

Enrollment

100

Registered

2018-09-01

Start date

2018-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with cirrhotic ascites with concomitant loop diuretic who showed body weight loss of 1.5 kg or more at 1 week after tolvaptan administration

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients over 20 years old 2)Patients who can walk by themselves 3)Patients who can describe themselves on a questionnaire form 4)Patients obtained written informed consent 5)Life expectancy of at least 1 year 6) 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: >=125mEq/L

Exclusion criteria

Exclusion criteria: 1) Poor cardiac organ function a) Patients with congestive 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 or had HIV 4) Patients taking dialysis 5) Patients with portal tumor thrombosis (Vp3 or Vp4) 6) Patients with hepatic encephalopathy 7) Patients with crucial digestive bleedings within 4 weeks 8) Patients had the following treatment a) Systemic chemotherapy within 4 weeks b) Being treated with invasive surgical therapy within 4 weeks 9) Patients with oral intake difficulty 10)Pregnant woman, lactating woman, or a woman suspected of pregnancy 11)Patients with severe allergic reaction to this study 12)Patients with drug abuse or psychological disorders 13) Patients concluded to be inappropriate to participate in this study by their physicians

Design outcomes

Primary

Measure	Time frame
To compare the differences in liver function (Alb value) and renal function (BUN, Cr, eGFR, cystatin C), before and 12 month after administering furosemide or azosemide	—

Countries

Japan

Contacts

Public ContactHideto Kawaratani

Nara Medical University The third department of internal medicine

kawara@naramed-u.ac.jp0744-22-3051(3415)

Outcome results