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

NCT02489864 | Unknown Phase 4

• 1 other identifier: 2005004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Terlipressin; mean arterial pressure; type 2 HRS

Outcome Measures

Primary Outcomes (1)

• HRS incidence rate

  one year

Study Arms (2)

Terlipressin and albumin

ACTIVE COMPARATOR

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

Albumin

PLACEBO COMPARATOR

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

Drug: Terlipressin

Interventions

Terlipressin DRUG

Albumin; Terlipressin and albumin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings;
• type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ;
• age 18 to65 years;
• 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;
• the absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis;
• the absence of findings suggestive of organic nephropathy;
• the absence of advanced hepatocellularcarcinoma.

You may not qualify if:

• Patients with history of coronary artery disease
• Cardiomyopathy
• Ventricular arrhythmia
• Obstructive arterial disease of limbs -

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Hepatorenal Syndrome

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Chan Xie, Dr.

CONTACT

8602085252372; happyxiechan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

CN (1)