Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis
Condition: Hepatorenal Syndrome
MeSH terms: Hepatorenal Syndrome; Syndrome
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): Terlipressin and albumin
Intervention type(s): Drug
Intervention description(s): Single-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days.
In addition to terlipressin, all patients received albumin at a dose of 1g per kg body weight during the first 24 hours, followed by 40g daily,targeted to obtain a central venous pressure (CVP) between 10 and 15 cm of water.
Other intervention name(s): - Glypressyn, Ferring SA, Saint-Prex, Switzerland.; - Albúmina Humana Grífols, Grífols , Barcelona, Spain.
Intervention MeSH terms: Terlipressin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type-1 HRS; active bacterial infections; terlipressin and albumin; kidney function