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

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Disease Information

Descriptive Information
Brief Title † The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure
Official Title †
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.
Detailed Description
Study Phase Phase 4
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure † HRS incidence rate
Secondary Outcome Measure †
Condition † Hepatorenal Syndrome
Intervention † DrugTerlipressin
Study Arms / Comparison Groups Terlipressin and albumin 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. Albumin Only albumin (Albumin 20 percent; Instituto Grífols, Barcelona, Spain) was given at a dose of 10 gram per day.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 30
Start Date † July 2015
Completion Date December 2017
Primary Completion Date July 2017
Eligibility Criteria † 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 38°C, heart rate >90 beats/min, respiration rate>20/min, and white-cell count 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 -
Gender Both
Ages 18 Years - 65 Years
Accepts Healthy Volunteers No
Contacts †† Chan Xie, Dr., 8602085252372, happyxiechan@hotmail.com
Location Countries † China
Administrative Information
NCT ID † NCT02489864
Organization ID 2005004
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Sun Yat-sen University
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date July 2015
First Received Date † July 1, 2015
Last Updated Date July 2, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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