A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal

Inclusion criteria

• Female or male patients ≥ 18 years of age
• Removal of at least 10 L of ascites in the preceding 2 months for symptom relief
• Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects
• Dietary sodium restriction <90 mcg/d.
• Serum creatinine levels of less than 1.8 mg/dL for at least 7 days before study entry.
• Total bilirubin levels of less than 3 mg/dL.
• Expected survival of greater than 6 months
• Written informed consent

Exclusion criteria

• Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
• Presence of peritoneal carcinomatosis
• Evidence of extensive ascites loculation
• Obstructive uropathy
• Coagulopathy that could not be corrected to a prothrombin time INR <1.8,
• Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3
• Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
• Any condition requiring emergency treatment
• Pregnancy
• Inability to obtain informed consent