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

Phase 2

Completed

• Conditions: Decompensated Cirrhosis; Portal Hypertension; Bleeding Varices; Refractory Ascites
• Interventions: Drug: L-ornithine-L-aspartate

• Registration Number: NCT01440829
• Lead Sponsor: Air Force Military Medical University, China

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.

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-27
• Study Start: 2011-12
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOLA group	L-ornithine-L-aspartate	Intervention: LOLA (30g per day) for a week.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China