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NCT Number: NCT01440829

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

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.

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Key information

Conditions

Decompensated Cirrhosis Ascites Bleeding Varices Digestive System Diseases Fibrosis Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Refractory Ascites

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cirrhotic patients with refractory ascites or at least one episode of variceal bleeding
  • No active bleeding within 5 days before TIPS
  • Child-Pugh score ≤ 11
  • Signed written informed consent

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 or benzodiazepine-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

Treatment and study plan

L-ornithine-L-aspartate

Drug

The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.

Primary outcomes

  1. Plasma ammonia

    Time frame: One week

    The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.

Secondary outcomes

  1. Incidence of hepatic encephalopathy

    Time frame: One week

  2. Liver function

    Time frame: One week

    The liver function (includes PT/INR, APTT, albumin, bilirubin, Child-Pugh score) at the first, fourth and seventh days after TIPS procedure.

  3. Psychometric tests

    Time frame: One week

    The results of the psychometric tests (include number connection test A, number connection test B, digit symbol test, serial dotting test, line tracing test) at the first, fourth and seventh days after TIPS procedure.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2011
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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