Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced cirrhosis characterized by marked renal failure and is associated with a very poor prognosis. Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously. It has been demonstrated that vasoconstrictor agents plus albumin are effective in the reversal of the renal failure. A large number of studies have shown that terlipressin improves renal function in patients with type 1 HRS; treatment is effective in 50-75% of patients approximately. Currently there are no specific studies about the treatment of type-1 HRS with ongoing infections.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Lypressin; Terlipressin

Criteria

Inclusion criteria:

• Cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, ultrasonographic, and/or endoscopic findings.

• Age between 18 and 85 years.

• Presence of sepsis, as defined by active infection, and signs of Systemic Inflammatory Response Syndrome.

• Occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria.

Exclusion criteria:

• Hepatocellular carcinoma outside the Milan criteria.

• Any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases.

• Septic or hypovolemic shock.

• Terminal condition (death expected in less than 48 hours).

• Lack of informed consent.