Ensayos clínicos

Inclusion Criteria

1. ≥ 21 years of age
2. Recurrence of grade 3 ascites requiring paracentesis for symptom relief more frequently than once per month for a minimum of 2 of the prior 3 months
3. Cirrhosis of any etiology
4. Failure to respond to or intolerance to high dose diuretics
5. Expected survival of greater than 3 months (MELD score ≤ 21)
6. Screened for varices and on optimal management
7. Diagnostic paracentesis with neutrophil count < 250 / µl within 24 hours of implantation
8. Written informed consent
9. Ability to comply with study procedures and ability to operate the device
10. Women of childbearing potential should use adequate contraception

Exclusion Criteria

1. Has had more than 2 systemic or local infections, such as peritonitis, urinary tract infection, or abdominal skin infection within the last 6 months
2. Presence of any current cancer
3. Evidence of extensive ascites loculation
4. Serum creatinine > 1.5 mg/dl
5. Serum bilirubin > 5 mg/dl
6. eGFR < 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method
7. Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to inclusion in the study
8. Hepatic encephalopathy > stage II in the two weeks prior to implant
9. Presence of a patent TIPS or surgical portosystemic shunt
10. Presence of Budd-Chiari syndrome
11. Previous solid organ transplant
12. Obstructive uropathy (bladder residual volume > 100ml (determined by catheterization or abdominal ultrasound) or any bladder anomaly which may contraindicate implantation of the alfapump, including recurrent urinary tract infections, vesicoureteral reflux, or history of urinary calculi)
13. International Prostate Symptom Score (I-PSS) ≥20
14. Thrombocytopenia < 45,000 X106/l
15. Patient undergoing therapeutic anticoagulation
16. Recent (<4 months) intra-abdominal foreign body or abdominal surgery, diaphragmatic hernia, abdominal surgery, severe abdominal adhesions, surgically irreparable hernia, abdominal wall or skin infection, or severe malnutrition
17. History (>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory or ischemic bowel disease, and frequent episodes of diverticulitis
18. Any non-liver disease with life expectancy < 1 year
19. Eligible for TIPS (unless they have refused TIPS placement)
20. Presence of any active implantable or body-worn devices that cannot be removed
21. Pregnancy
22. Being in another therapeutic clinical study