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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02489864

Enrollment

Registered

2015-07-03

Start date

2015-07-31

Completion date

2017-12-31

Last updated

2015-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatorenal Syndrome

Keywords

Terlipressin, mean arterial pressure, type 2 HRS

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.

Interventions

DRUGTerlipressin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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 -

Design outcomes

Primary

Measure	Time frame
HRS incidence rate	one year

Countries

China

Contacts

Primary ContactChan Xie, Dr.

happyxiechan@hotmail.com8602085252372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026