The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS

Last updated: December 18, 2012
Sponsor: Fourth Military Medical University
Overall Status: Completed

Phase

2/3

Condition

Diabetes And Hypertension

Scar Tissue

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT01440829
LOLA-TIPS
  • Ages 18-65
  • All Genders

Study Summary

The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cirrhotic patients with refractory ascites or at least one episode of varicealbleeding

  • No active bleeding within 5 days before TIPS

  • Child-Pugh score ≤ 11

  • Signed written informed consent

Exclusion

Exclusion Criteria:

  • An age < 18 years or > 65 years

  • With TIPS contraindications

  • Using drugs for hepatic encephalopathy such as neomycin, rifaximin, lactulose,lactitol or branched-chain amino acid.

  • Intake of psychostimulants, sedatives, antidepressants, benzodiazepines orbenzodiazepine-antagonists

  • Past or present history of hepatic encephalopathy

  • Pregnancy or breast-feeding

  • Hepatic carcinoma and/or other malignancy diseases

  • Sepsis

  • Spontaneous bacterial peritonitis

  • Uncontrollable hypertension

  • Serious cardiac or pulmonary dysfunction

  • Renal failure

  • Portal vein thrombosis

  • History of organ transplantation

  • History of HIV (human immunodeficiency viruses) infection

Study Design

Total Participants: 40
Study Start date:
December 01, 2011
Estimated Completion Date:
December 31, 2012

Study Description

Patients with successful TIPS deployment are randomized to LOLA arm and blank control arm. Plasma ammonia concentrations are measured before TIPS, day 1, day 4 and day 7 after TIPS.

Connect with a study center

  • Xijing Hospital of Digestive Diseases, Fourth Military Medical University

    Xi`an, Shaanxi 710032
    China

    Site Not Available

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