Bleeding Varices, Decompensated Cirrhosis, Portal Hypertension, Refractory Ascites
Conditions
Keywords
Transjugular Intrahepatic Portosystemic Shunt, TIPS, Liver Cirrhosis, LOLA, L-ornithine-L-aspartate, Refractory Ascites
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.
Interventions
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma ammonia | One week | The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed