Clinical Trial: Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Terlipressin and Albumin in Patients With Type-1 Hepatorenal Syndrome Associated With Sepsis

Brief 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.

Detailed Summary:

All consecutive patients with cirrhosis hospitalized with an infection or who developed an infection during hospitalization for an acute decompensation of the disease in four university hospitals.

Criteria for inclusion were: 1/ cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, ultrasonographic, and/or endoscopic findings; 2/ age between 18 and 80 years; 3/ presence of sepsis, as defined by infection and signs of Systemic Inflammatory Response Syndrome; and 4/ occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria. Exclusion criteria were: 1/ hepatocellular carcinoma outside the Milan criteria; 2/ any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases; 3/ septic or hypovolemic shock; 4/ terminal condition (death expected in less than 48 hours); and 5/ lack of informed consent.

Aim: A proof of concept study to evaluate whether treatment with terlipressin and albumin in the course of an infection associated with type-1 HRS is effective and safe.


Sponsor: Hospital Clinic of Barcelona

Current Primary Outcome: Change in serum creatinine values [ Time Frame: baseline and 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • changes in glomerular filtration rate [ Time Frame: at 3 days and 14 days ]
  • Changes in arterial pressure [ Time Frame: baseline to 14 days ]
  • changes in plasma renin activity [ Time Frame: at 3 days and 14 days ]
  • changes in norepinephrine concentration [ Time Frame: at 3 days and 14 days ]


Original Secondary Outcome: Same as current

Information By: Hospital Clinic of Barcelona

Dates:
Date Received: August 14, 2013
Date Started: December 2012
Date Completion:
Last Updated: September 4, 2013
Last Verified: September 2013