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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial

Conditions
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Decompensated Cirrhosis, Portal Hypertension, Bleeding Varices, Refractory Ascites

Intervention / Treatment
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* Drug: L-ornithine-L-aspartate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOLA group<br>Intervention: LOLA (30g per day) for a week. | Drug: L-ornithine-L-aspartate<br>* The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.<br>|
| No Intervention: Control group<br>Patients will not be treated with LOLA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma ammonia | The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure. | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hepatic encephalopathy |  | One week | 
| Liver function | The liver function (includes PT/INR, APTT, albumin, bilirubin, Child-Pugh score) at the first, fourth and seventh days after TIPS procedure. | One week | 
| 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. | One week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TIPS, Transjugular Intrahepatic Portosystemic Shunt, Liver Cirrhosis, LOLA, L-ornithine-L-aspartate, Refractory Ascites