Clinical trial NCT01932151: Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis
Official title: Terlipressin and Albumin in Patients With Type-1 Hepatorenal Syndrome Associated With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatorenal Syndrome
Keywords: type-1 HRS
active bacterial infections
terlipressin and albumin
kidney function
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Change in serum creatinine values
timeFrame: baseline and 14 days
Secondary outcomes:
measure: changes in glomerular filtration rate
timeFrame: at 3 days and 14 days
measure: Changes in arterial pressure
timeFrame: baseline to 14 days
measure: changes in plasma renin activity
timeFrame: at 3 days and 14 days
measure: changes in norepinephrine concentration
timeFrame: at 3 days and 14 days
Other outcomes:
measure: Presence of adverse effects
timeFrame: 14 days
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinc of Barcelona
name: Pere Ginès, MD
role: PRINCIPAL_INVESTIGATOR
References: