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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University
• Treatments: N-Methylaspartate

Criteria

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