The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
|ClinicalTrials.gov Identifier: NCT01440829|
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : December 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Decompensated Cirrhosis Portal Hypertension Bleeding Varices Refractory Ascites||Drug: L-ornithine-L-aspartate||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial|
|Study Start Date :||December 2011|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Experimental: LOLA group
Intervention: LOLA (30g per day) for a week.
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
No Intervention: Control group
Patients will not be treated with LOLA.
- Plasma ammonia [ Time Frame: One week ]The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.
- Incidence of hepatic encephalopathy [ Time Frame: One week ]
- Liver function [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440829
|Xijing Hospital of Digestive Diseases, Fourth Military Medical University|
|Xi`an, Shaanxi, China, 710032|
|Principal Investigator:||Guohong Han, PhD & MD||Xijing Hospital of Digestive Diseases, Fourth Military Medical University|