Refractory Ascites
Conditions
Brief summary
The purpose of this study is to determine whether the Automatic Fluid Shunt (AFS) can reduce the number of paracentesis procedures in patients with refractory ascites.
Interventions
DEVICEAFS System
AFS System with patient specific flow rate
Sponsors
NovaShunt AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of paracentesis procedures required | 6 month |
Countries
Czechia
Outcome results
None listed