Multicenter study of the patients with refractory ascites.

Multicenter study of the patients with refractory ascites. - Multicenter study of the patients with refractory ascites.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033221

Enrollment

Registered

2018-08-01

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

Liver cirrhosis with refractory ascites.

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 12 weeks 6)Patients taking diuretics with furosemide 80 mg or less and / or spironolactone 100 mg or less 7) 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) Inadequate 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 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 this study 14)Patients with drug abuse or psychological disorders 15) Patients concluded to be inappropriate to participate in this study by their physicians

Design outcomes

Primary

Measure	Time frame
The number of times of paracentesis and CART, and the total puncture drainage volume.	—

Secondary

Measure	Time frame
Changes of QOL by questionnaire. Body weight change (comparison between registration date and each measurement date). Changes in liver function and renal function.	—

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