Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis

Hepatorenal Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932151
• Other study ID #: GIN-TER-2010-01
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: September 4, 2013
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatorenal Syndrome
• Syndrome

Intervention

Drug:
• Terlipressin and albumin
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.

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of adverse effects		14 days	Yes
Primary	Change in serum creatinine values		baseline and 14 days	No
Secondary	changes in glomerular filtration rate		at 3 days and 14 days	No
Secondary	Changes in arterial pressure		baseline to 14 days	No
Secondary	changes in plasma renin activity		at 3 days and 14 days	No
Secondary	changes in norepinephrine concentration		at 3 days and 14 days	No