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

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ClinicalTrials.gov Identifier: NCT01440829
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

Brief 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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012


Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Guohong Han, Principal Investigator, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01440829     History of Changes
Other Study ID Numbers: LOLA-TIPS
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

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

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