Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Exclusion Criteria

• •Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
• •Total bilirubin \> 5 mg/dL
• •Blood clotting International normalized ratio (INR) \> 2.5
• •Serum creatinine \> 2.0 mg/dL
• •Current or recent (within 3 months of consent) renal dialysis
• •Hepatic encephalopathy grade 3 or 4
• •Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom \[Amanita\] poisoning)
• •Current or recent treatment (within 7 days) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
• •Respiratory failure requiring positive airway pressure devices or intubation
• •SIRS/sepsis episode in the previous 28 days from consent
• •Episode of spontaneous bacterial peritonitis or gastrointestinal hemorrhage within 28 days of consent
• •Ongoing documented or suspected infection
• •Severe cardiovascular disease that are contraindication to terlipressin therapy such as advanced arteriosclerosis, arrhythmia, coronary insufficiency or uncontrolled hypertension
• •Findings suggestive of organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive or other renal pathology)
• •Severe comorbidity that in the opinion of the Investigator would affect short-term prognosis and/or disallow safe participation in the trial (such as for example, severe anemia or pancytopenia, advanced neoplasia, hepatocellular carcinoma \[confirmed with serum alpha1-fetoprotein testing\], severe chronic obstructive pulmonary disease or asthma)
• •Alcoholics who have not been abstinent for the past 6 months
• •Transjugular intrahepatic portosystemic shunt or other surgical shunt
• •For female patients: Confirmed pregnancy
• •Known allergy or hypersensitivity to terlipressin
• •Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of consent.