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

Hepatorenal Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02489864
• Other study ID #: 2005004
• Status: Recruiting
• Phase: Phase 4
• First received: July 1, 2015
• Last updated: July 2, 2015
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Sun Yat-sen University
• Contact: Chan Xie, Dr.
• Phone: 8602085252372
• Email: happyxiechan[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatorenal Syndrome

Intervention

Drug:
• Terlipressin

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRS incidence rate		one year	No