Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Inclusion criteria

• Chronic, or acute liver disease
• Rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to >2.5 mg/dL in less than two weeks.
• No sustained improvement in renal function after diuretic withdrawal and plasma volume expansion
• Proteinuria <500 mg per day
• No evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease

Exclusion criteria

• Ongoing shock
• Uncontrolled bacterial infection
• Current significant fluid losses
• Current or recent treatment with nephrotoxic drugs (e.g. NSAIDs or aminoglycosides within 4 weeks)
• Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose)
• Confirmed pregnancy
• Severe cardiovascular disease
• Evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis)
• Participation in other clinical studies within 30 days