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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01440829
First received: September 21, 2011
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Decompensated Cirrhosis
Portal Hypertension
Bleeding Varices
Refractory Ascites
Drug: L-ornithine-L-aspartate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • Plasma ammonia [ Time Frame: One week ] [ Designated as safety issue: No ]
    The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.


Secondary Outcome Measures:
  • Incidence of hepatic encephalopathy [ Time Frame: One week ] [ Designated as safety issue: No ]
  • Liver function [ Time Frame: One week ] [ Designated as safety issue: No ]
    The liver function (includes PT/INR, APTT, albumin, bilirubin, Child-Pugh score) at the first, fourth and seventh days after TIPS procedure.

  • Psychometric tests [ Time Frame: One week ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LOLA group
Intervention: LOLA (30g per day) for a week.
Drug: L-ornithine-L-aspartate
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
No Intervention: Control group
Patients will not be treated with LOLA.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440829

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi`an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Guohong Han, PhD & MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University
  More Information

Publications:
Responsible Party: Guohong Han, Principal Investigator, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01440829     History of Changes
Other Study ID Numbers: LOLA-TIPS
Study First Received: September 21, 2011
Last Updated: December 18, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fourth Military Medical University:
Transjugular Intrahepatic Portosystemic Shunt
TIPS
Liver Cirrhosis
LOLA
L-ornithine-L-aspartate
Refractory Ascites

Additional relevant MeSH terms:
Ascites
Hemorrhage
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Varicose Veins
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014