A prospective, observational add on study to evaluate the effect of L Ornithine LAspartate (LOLA) on clinical outcomes in overt hepatic encephalopathy patients on lactulose and rifaximin vsrifaximin and lactulose
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- 1. To determine the change in neurological status by West Haven scoring at the end of 1
研究概览
简要总结
Hepatic encephalopathy (HE) is a reversible syndrome of impaired brain function occurring in patients with advanced liver disease. These patients may present initially with sleep-wake cycle disturbance, personality changes and cognitive, motor activity and coordination dysfunctions, which will eventually progress to stupor, coma and death. It also affects the quality of life and patient survival.
Data on the use of intravenous L-ornithine L-aspartate (LOLA) in the treatment of overt HE (OHE) is limited.
In this study LOLA, a branched chain amino acid will be investigated for reversing the clinical symptoms in hepatic encephalopathy patients.
A sample size of 53 was calculated . Considering unequal group sizes, 19 patients will be included in Group I and 34 in Group II (roughly 1:2 ratio)
Group I – Subjects will receive iv LOLA (20-30 g over 2-3 hrs ) for 3- 7days + standard
background therapy
Group II - Subjects will receive only standard background therapy
Standard background therapy- All the patients will be receiving Syrup lactulose 30 ml OD and Tab Rifaximin 550 mg BD throughout the study for 1 week .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •In-Patients diagnosed of Overt Hepatic Encephalopathy (Grade 2 or more) according to West Haven’s criteria who are on lactulose and rifaximin 2)Subjects/ LARs willing to comply with the study procedures and willing to give written informed consent 3) Patients should be capable to comprehend letters and numbers.
排除标准
- •Pregnant and lactating women 2) History of hypersensitivity to any drug or the study drug 3) History of intake of any drugs that may interfere with CNS activity 4) Subjects with pre existing medical conditions like cardiac , pulmonary or neurological disease/psychiatric disorder which in the judgement of the clinician would interfere with the study 5) Serum creatinine > 3 mg/dl.
结局指标
主要结局
1. To determine the change in neurological status by West Haven scoring at the end of 1
时间窗: 1 week
week from the baseline
时间窗: 1 week
次要结局
- 1. To determine change in fasting serum ammonia at the end of 1 week from the baseline(visit)