Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites
Condition: Cirrhosis; Ascites Hepatic
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Intervention: Terlipressin acetate continuous infusion
Intervention description: Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
Intervention MeSH terms: Terlipressin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label prospective study in a cohort of 6 patients
Masking: None (Open Label)
Masking description: Open label
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Terlipressin; Terlipressin acetate

Summary:

      Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients
      with refractory ascites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with cirrhosis and refractory ascites who required 3 or more large volume (4
             liters and more) paracenteses in the previous 60 days

        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.