Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)
研究概览
简要总结
One of the most significant goals of hepatic encephalopathy (HE) treatment is to reduce ammonia levels by lowering its synthesis and enhancing its detoxification which can be achieved by using non-absorbable disaccharides, antibiotics, branched-chain amino acids (BCAA), L-ornithine L-aspartate (LOLA), and probiotics.
LOLA decreases ammonia, therefore, it is presumed to decrease agitated delirium in HE patients and thus decrease their need for other sedatives. On the other hand, BCAA improve mental function in HE patients by increasing the detoxification of ammonia in muscles.
详细描述
The most often utilized criteria for grading HE are the West Haven criteria (WHC). This grading distinguishes four levels of clinically evident hepatic encephalopathy.
West Haven criteria (WHC): [R]
Stage Consciousness
-
Normal
-
Mild lack of awareness
-
Lethargic
-
Somnolent but arousable
-
Coma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Liver cirrhosis based on clinical, biochemical, radiological and/or histopathology.
- •Patients having overt HE, West Haven criteria (WHC) grade III-IV.
排除标准
- •Age < 21 years.
- •Inability to obtain an informed consent from the first degree relative and/or legally authorized representative.
- •Advanced cardiac or pulmonary disease.
- •Presence of underlying chronic renal failure (serum creatinine > 3 mg/dL).
- •Neurodegenerative disease (including head injury and drug intoxication).
- •Major psychiatric illness.
- •Use of sedatives or antidepressants.
- •Pregnancy or breast-feeding .
- •Hepatocellular carcinoma.
- •Acute on top of chronic liver failure.
研究组 & 干预措施
Group 1 (Treatment group)
干预措施: Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA) (Drug)
Group 2 (Control group)
干预措施: Branched-chain amino acids (BCAA), enriched solution (Aminoleban) (Drug)
结局指标
主要结局
Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)
时间窗: 5 days of treatment
Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)
次要结局
未报告次要终点
研究者
Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University