Clinical Trials

Inclusion Criteria

• Written informed consent by subject or legally authorized representative
• At least age 18 years
• Cirrhosis and ascites
• Rapidly progressive reduction in renal function characterized by
  • SCr ≥ 2.5 mg/dL
  • Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based criteria for proportional increases likely to be representative of at least a doubling within 2 weeks
• No sustained improvement in renal function (< 20% decrease in SCr and SCr ≥ 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin
  • Albumin doses recommended by the IAC are 1 g/kg on the first day (Maximum 100 g) and 20 - 40 g/day thereafter as clinically indicated
  • It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period
  • The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge
  • The qualifying SCr value must be ≥ 2.25 mg/dL and at least 80% of the diagnostic (pre-fluid challenge) SCr value

Exclusion Criteria

• Serum Creatinine > 7 mg/dL
• Shock hypotension mean arterial pressure < 70 mm Hg, or a decrease > 40 mm Hg in systolic blood pressure from baseline, with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation
• Sepsis or systemic inflammatory response syndrome (SIRS) 
  • Presence of 2 or more of the following findings
    • Temperature > 38°C or < 36°C
    • Heart rate > 90/min
    • Respiratory rate of > 20/min
    • PaCO2 of < 32 mm Hg
    • White blood cell count of > 12,000 cells/µL or < 4,000/ µL
  • A septic documented infection and systemic inflammatory response syndrome
  • < 2 days anti-infective therapy for documented or suspected infection
• Proteinuria > 500 mg/day
• Hematuria or microhematuria (> 50 red blood cells per high power field)
• Clinically significant casts on urinalysis, including granular casts 
  • Urine sediment examination is required to exclude presence of granular casts and other clinically significant casts (e.g., red blood cell [RBC] casts)
• Evidence of intrinsic or parenchymal renal disease (including acute tubular necrosis)
• Obstructive uropathy or other renal pathology on ultrasound or other medical imaging
• Current or recent treatment (within 4 weeks) with nephrotoxic drugs, e.g., aminoglycosides, nonsteroidal anti-inflammatory drugs (NSAID)
  • Up to 3 doses of an NSAID within the prior month (prescription or over the counter) is acceptable 
  • Use of short-term (< 2 weeks) oral neomycin for acute encephalopathy is acceptable
• Current or recent (within 4 weeks) renal replacement therapy
• 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 48 hours) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
• Severe cardiovascular disease as judged by investigator
• Estimated life expectancy of less than 3 days
• Confirmed pregnancy
• Known allergy or sensitivity to terlipressin or another component of the study treatment
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization