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The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure

Primary Purpose

Hepatorenal Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Terlipressin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatorenal Syndrome focused on measuring Terlipressin, mean arterial pressure, type 2 HRS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings;
  2. type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ;
  3. age 18 to65 years;
  4. absence of severe bacterial infection associated with findings of systemic inflammatory response as diagnosedby the presence of at least 2 of the following criteria: body temperature <36°C or >38°C, heart rate >90 beats/min, respiration rate>20/min, and white-cell count <4 or >12 X106/L or >6% of band forms; patients with bacterial infections, however, could be included in the study if renal failure persisted after infection resolution;
  5. the absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis;
  6. the absence of findings suggestive of organic nephropathy;
  7. the absence of advanced hepatocellularcarcinoma.

Exclusion Criteria:

  1. Patients with history of coronary artery disease
  2. Cardiomyopathy
  3. Ventricular arrhythmia
  4. Obstructive arterial disease of limbs -

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Terlipressin and albumin

Albumin

Arm Description

Patients in this group received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour. albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day.

Only albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day.

Outcomes

Primary Outcome Measures

HRS incidence rate

Secondary Outcome Measures

Full Information

First Posted
July 1, 2015
Last Updated
July 2, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02489864
Brief Title
The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

5. Study Description

Brief Summary
Appreciation of the central role for arterial vasodilatation in the pathogenesis of hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with albumin as a medical therapy for HRS. Terlipressin have been explored but the optimal approach for such therapies has not yet been established. As compared with albumin, treatment with terlipressin and albumin is effective in improving renal function in patients with cirrhosis and hepatorenal syndrome. Our previous study showed that mean arterial pressure (MAP) is a predictor of hepatorenal syndrome occurrence in cirrhotic patients with ascites. The purpose of this study was to examine the role of targeting an early and substantial increase in mean arterial pressure in the prevention of type 2 HRS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatorenal Syndrome
Keywords
Terlipressin, mean arterial pressure, type 2 HRS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Terlipressin and albumin
Arm Type
Active Comparator
Arm Description
Patients in this group received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour. albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day.
Arm Title
Albumin
Arm Type
Placebo Comparator
Arm Description
Only albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day.
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Primary Outcome Measure Information:
Title
HRS incidence rate
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings; type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ; age 18 to65 years; absence of severe bacterial infection associated with findings of systemic inflammatory response as diagnosedby the presence of at least 2 of the following criteria: body temperature <36°C or >38°C, heart rate >90 beats/min, respiration rate>20/min, and white-cell count <4 or >12 X106/L or >6% of band forms; patients with bacterial infections, however, could be included in the study if renal failure persisted after infection resolution; the absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis; the absence of findings suggestive of organic nephropathy; the absence of advanced hepatocellularcarcinoma. Exclusion Criteria: Patients with history of coronary artery disease Cardiomyopathy Ventricular arrhythmia Obstructive arterial disease of limbs -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chan Xie, Dr.
Phone
8602085252372
Email
happyxiechan@hotmail.com
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Xie, Dr.
Phone
8602085252372
Email
happyxiechan@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure

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