Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis
Primary Purpose
Hepatorenal Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Terlipressin and albumin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatorenal Syndrome focused on measuring type-1 HRS, active bacterial infections, terlipressin and albumin, kidney function
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.
Sites / Locations
- Hospital Clinic de Barcelona
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Terlipressin and albumin
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in serum creatinine values
Secondary Outcome Measures
changes in glomerular filtration rate
Changes in arterial pressure
changes in plasma renin activity
changes in norepinephrine concentration
Full Information
NCT ID
NCT01932151
First Posted
August 14, 2013
Last Updated
September 4, 2013
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01932151
Brief Title
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
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatorenal Syndrome
Keywords
type-1 HRS, active bacterial infections, terlipressin and albumin, kidney function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Terlipressin and albumin
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Terlipressin and albumin
Other Intervention Name(s)
- Glypressyn, Ferring SA, Saint-Prex, Switzerland., - Albúmina Humana Grífols, Grífols , Barcelona, Spain.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum creatinine values
Time Frame
baseline and 14 days
Secondary Outcome Measure Information:
Title
changes in glomerular filtration rate
Time Frame
at 3 days and 14 days
Title
Changes in arterial pressure
Time Frame
baseline to 14 days
Title
changes in plasma renin activity
Time Frame
at 3 days and 14 days
Title
changes in norepinephrine concentration
Time Frame
at 3 days and 14 days
Other Pre-specified Outcome Measures:
Title
Presence of adverse effects
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Ginès, MD
Organizational Affiliation
Hospital Clinc of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis
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