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Clinical Efficacy Study of the Ascites Concentration, Filtration, and Reinfusion System (A-CFRS) in the Treatment of Moderate to Massive Ascites Associated with Liver Cirrhosis

Clinical Efficacy Study of the Ascites Concentration, Filtration, and Reinfusion System (A-CFRS) in the Treatment of Moderate to Massive Ascites Associated with Liver Cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125175
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-05-21
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Cirrhotic ascites

Interventions

Trial group:Conventional diuretics (furosemide 40mg + spironolactone 100mg once daily) + ascites concentration filtration reinfusion (A-CFRS) + immediate intravenous albumin 10g infusion
Control group:Conventional diuretics (furosemide 40mg + spironolactone 100mg once daily) + large-volume paracentesis (LVP) + human serum albumin 10g per day

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years (inclusive), with no gender restrictions; 2. Meets the diagnostic criteria for moderate to massive ascites associated with liver cirrhosis as outlined in the "Guidelines for the Diagnosis and Treatment of Ascites Due to Liver Cirrhosis (2023 Edition)."; 3. After at least one week of treatment with conventional diuretics (40 mg of Furosemide + 100 mg of Spironolactone once daily) and an appropriate amount of human albumin, there has been a poor response to ascites treatment (decrease of less than one grade); 4. Capable of independent behavior, voluntarily willing to participate in the clinical study, and has signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of allergies to extracorporeal circulation equipment, blood purification devices, etc.; 2. Platelet count (PLT) less than 50 × 10^9/L; 3. Patients with liver failure (patients with acute-on-chronic liver failure should meet the criteria in the "Guidelines for the Diagnosis and Treatment of Acute-on-Chronic Liver Failure (2025 Edition)"; others should comply with the "Guidelines for the Diagnosis and Treatment of Liver Failure (2024 Edition)"). 4. Patients with gastrointestinal bleeding within the last two weeks; 5. Patients with hepatic encephalopathy grade II or higher; 6. Patients with severe heart or lung diseases; unstable vital signs; 7. Patients with renal insufficiency or other clear kidney diseases, with a glomerular filtration rate less than 50 ml/min/1.73 m^2 or urine output less than 800 ml/day; nephrotic syndrome. 8. Patients with chylous ascites; 9. Patients with hyperkalemia; 10. Patients with malignant tumors such as liver cancer, gastric cancer, or colon cancer; 11. Patients with a history of kidney or liver transplantation; 12. Individuals with a history of mental illness or substance abuse; 13. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Time to ascites resolution;

Secondary

MeasureTime frame
Rate of ascites resolution;Time to relief of abdominal distension symptoms and relief rate;Reduction in weight and abdominal circumference;Serum albumin;Child-Pugh score;MELD score;Demand for human albumin;Time to recurrence of moderate to massive ascites after treatment;Quality of life assessment;28-day and 90-day survival rates;

Countries

China

Contacts

Public ContactChen Yu

Beijing You’an Hospital, Capital Medical University,

chybeyond1071@ccmu.edu.cn+86 10 8399 7156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026