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

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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis High Blood Pressure Varicose Veins

Drug Information available for: Aspartic acid Ornithine Ammonia

U.S. FDA Resources

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

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:

Stauch S, Kircheis G, Adler G, Beckh K, Ditschuneit H, Görtelmeyer R, Hendricks R, Heuser A, Karoff C, Malfertheiner P, Mayer D, Rösch 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.

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.

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.

Nolte W, Wiltfang J, Schindler C, Münke 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.

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 May 21, 2013