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

NCT ID: NCT02489864

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Hepatorenal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study 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.

Group Type: ACTIVE_COMPARATOR

Terlipressin

Intervention Type: DRUG

Albumin

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

Group Type: PLACEBO_COMPARATOR

Terlipressin

Intervention Type: DRUG

Interventions

Terlipressin

Intervention Type: DRUG

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 <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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Chan Xie

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chan Xie, Dr.

Role: CONTACT

happyxiechan@hotmail.com

8602085252372

Facility Contacts

Chan Xie, Dr.

Role: primary

happyxiechan@hotmail.com

8602085252372

Other Identifiers

2005004

Identifier Type: -

Identifier Source: org_study_id