Status:
COMPLETED
The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
Lead Sponsor:
Air Force Military Medical University, China
Conditions:
Decompensated Cirrhosis
Portal Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01440829
Start Date
December 1 2011
End Date
December 1 2012
Last Update
December 19 2012
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032