The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
NCT ID: NCT01440829
Last Updated: 2012-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2011-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LOLA group
Intervention: LOLA (30g per day) for a week.
L-ornithine-L-aspartate
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
Control group
Patients will not be treated with LOLA.
No interventions assigned to this group
Interventions
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L-ornithine-L-aspartate
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
Eligibility Criteria
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Inclusion Criteria
* No active bleeding within 5 days before TIPS
* Child-Pugh score ≤ 11
* Signed written informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Guohong Han
Principal Investigator
Principal Investigators
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Guohong Han, PhD & MD
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Locations
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Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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LOLA-TIPS
Identifier Type: -
Identifier Source: org_study_id