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A random-control study of PMMA membrane as a filtrating agent of ascites in cell-free and concentrated ascites rein fusion therapy (CART) against patients with refractory ascites

A random-control study of PMMA membrane as a filtrating agent of ascites in cell-free and concentrated ascites rein fusion therapy (CART) against patients with refractory ascites - A random-control study of CART using PMMA membrane against patients with refractory ascites

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031393
Enrollment
20
Registered
2018-02-21
Start date
2015-01-01
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

refractory ascites

Interventions

Polystyrene(PS) membrane group Use polystyrene membrane when concentrating ascites before performing CART. Use day 1 only. polymethylmethacrylate(PMMA) membrane group Use polymethylmethacrylate memb

Sponsors

Third Department of Internal Medicine, Nara Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Liver cirrhosis patients with refractory ascites of age 20 years or older (without gender) 2) Regarding participation in this study, please give sufficient explanation to yourself before starting the exam and consent by the document by the person The obtained patient 3) Patients who are expected to survive for 4 weeks or more 4) Patients meeting the following clinical testing criteria a) Hemoglobin: > 8.0 g / dl b) Neutrophils: > 1500 / mm3 c) Platelets: > 30000 / mm3 d) Total bilirubin: <4.0 mg / dL e) ALT and AST: < 6 times facility standard f) Serum creatinine: < 2.0 g) Serum sodium concentration: > 120 mEq / L

Exclusion criteria

Exclusion criteria: 1) Patients with heart disease corresponding to the following a) Patients with NYHA class 3 or higher congestive heart failure b) Patients with poorly controlled hypertension 2) Patients with severe and active infections (excluding HBV and HCV) 3) Patients with history of HIV infection 4) Patients during hemodialysis 5) Patients with portal vein tumor plugs with Vp3 or more 6) Patients with hepatic encephalopathy who are difficult to properly hydrate 7) Patients who had gastrointestinal bleeding which clinically becomes problem within 4 weeks before the start of the study 8) Patients who received treatment corresponding to the following a) Systemic chemotherapy b) Invasive surgery within 4 weeks before the start of the study 9) Pregnant women Patients who have a possibility or intent during lactation and pregnancy 10) Patients who may have an allergic reaction to this test device 11) Health condition, psychological state, social situation that interferes with substance abuse, participation in this study and evaluation of results Patient involved 12) In addition, if there is a possibility of impairing patient safety in conducting this examination, or When it is judged that compliance is difficult

Design outcomes

Primary

MeasureTime frame
fever up within 24 hours after CART

Secondary

MeasureTime frame
duration of next CART session

Countries

Japan

Contacts

Public ContactMitsuteru Kitade

Nara Medical University Third Department of Internal Medicine

kitadem@naramed-u.ac.jp0744223051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026