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

Primary Purpose

Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
L-ornithine-L-aspartate
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis focused on measuring Transjugular Intrahepatic Portosystemic Shunt, TIPS, Liver Cirrhosis, LOLA, L-ornithine-L-aspartate, Refractory Ascites

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LOLA group

Control group

Arm Description

Intervention: LOLA (30g per day) for a week.

Patients will not be treated with LOLA.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2011
Last Updated
December 18, 2012
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01440829
Brief Title
The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices, Refractory Ascites
Keywords
Transjugular Intrahepatic Portosystemic Shunt, TIPS, Liver Cirrhosis, LOLA, L-ornithine-L-aspartate, Refractory Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LOLA group
Arm Type
Experimental
Arm Description
Intervention: LOLA (30g per day) for a week.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will not be treated with LOLA.
Intervention Type
Drug
Intervention Name(s)
L-ornithine-L-aspartate
Intervention Description
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
Primary Outcome Measure Information:
Title
Plasma ammonia
Description
The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.
Time Frame
One week
Secondary Outcome Measure Information:
Title
Incidence of hepatic encephalopathy
Time Frame
One week
Title
Liver function
Description
The liver function (includes PT/INR, APTT, albumin, bilirubin, Child-Pugh score) at the first, fourth and seventh days after TIPS procedure.
Time Frame
One week
Title
Psychometric tests
Description
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.
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohong Han, PhD & MD
Organizational Affiliation
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
9625322
Citation
Stauch S, Kircheis G, Adler G, Beckh K, Ditschuneit H, Gortelmeyer R, Hendricks R, Heuser A, Karoff C, Malfertheiner P, Mayer D, Rosch W, Steffens J. Oral L-ornithine-L-aspartate therapy of chronic hepatic encephalopathy: results of a placebo-controlled double-blind study. J Hepatol. 1998 May;28(5):856-64. doi: 10.1016/s0168-8278(98)80237-7.
Results Reference
background
PubMed Identifier
10462368
Citation
Rose C, Michalak A, Rao KV, Quack G, Kircheis G, Butterworth RF. L-ornithine-L-aspartate lowers plasma and cerebrospinal fluid ammonia and prevents brain edema in rats with acute liver failure. Hepatology. 1999 Sep;30(3):636-40. doi: 10.1002/hep.510300311.
Results Reference
background
PubMed Identifier
10986219
Citation
Rees CJ, Oppong K, Al Mardini H, Hudson M, Record CO. Effect of L-ornithine-L-aspartate on patients with and without TIPS undergoing glutamine challenge: a double blind, placebo controlled trial. Gut. 2000 Oct;47(4):571-4. doi: 10.1136/gut.47.4.571.
Results Reference
background
PubMed Identifier
9794904
Citation
Nolte W, Wiltfang J, Schindler C, Munke H, Unterberg K, Zumhasch U, Figulla HR, Werner G, Hartmann H, Ramadori G. Portosystemic hepatic encephalopathy after transjugular intrahepatic portosystemic shunt in patients with cirrhosis: clinical, laboratory, psychometric, and electroencephalographic investigations. Hepatology. 1998 Nov;28(5):1215-25. doi: 10.1002/hep.510280508.
Results Reference
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The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS

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