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Completed

NCT Number: NCT01932151

Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Terlipressin and albumin

Drug

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 names: - Glypressyn, Ferring SA, Saint-Prex, Switzerland., - Albúmina Humana Grífols, Grífols , Barcelona, Spain.

Primary outcomes

  1. Change in serum creatinine values

    Time frame: baseline and 14 days

Secondary outcomes

  1. changes in glomerular filtration rate

    Time frame: at 3 days and 14 days

  2. Changes in arterial pressure

    Time frame: baseline to 14 days

  3. changes in plasma renin activity

    Time frame: at 3 days and 14 days

  4. changes in norepinephrine concentration

    Time frame: at 3 days and 14 days

Other outcomes

  1. Presence of adverse effects

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2013
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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