Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489864
Recruitment Status : Unknown
Verified July 2015 by Chan Xie, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Chan Xie, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Hepatorenal Syndrome Drug: Terlipressin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

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



Primary Outcome Measures :
  1. HRS incidence rate [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489864


Contacts
Layout table for location contacts
Contact: Chan Xie, Dr. 8602085252372 happyxiechan@hotmail.com

Locations
Layout table for location information
China, Guangdong
The Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Chan Xie, Dr.    8602085252372    happyxiechan@hotmail.com   
Sponsors and Collaborators
Sun Yat-sen University

Layout table for additonal information
Responsible Party: Chan Xie, Doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02489864     History of Changes
Other Study ID Numbers: 2005004
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Keywords provided by Chan Xie, Sun Yat-sen University:
Terlipressin
mean arterial pressure
type 2 HRS
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatorenal Syndrome
Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents