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

Air Force Military Medical University of People's Liberation Army

Status and phase

Completed

Phase 3

Phase 2

Conditions

Portal Hypertension

Decompensated Cirrhosis

Refractory Ascites

Bleeding Varices

Treatments

Drug: L-ornithine-L-aspartate

Study type

Interventional

Funder types

Other

Identifiers

NCT01440829

LOLA-TIPS

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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