The Infusion of L-Ornithine L-aspart is as Effective as Nonabsorbable Disaccharides in the Management of Acute Hepatic Encephalopathy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement of at least one grade in mental state based on the West Haven Criteria
研究概览
简要总结
Hepatic encephalopathy is caused by the effects on the brain of substances that under normal circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor responsible for the development of hepatic encephalopathy. In patients with cirrhosis, the reduction in hepatocellular function and generation of portosystemic shunts contribute to increase serum ammonium. The current therapeutic approaches, are aimed at reducing blood ammonium levels.
Administration of the non-absorbable disaccharides, have become standard treatment of hepatic encephalopathy.There are no adequate clinical trials comparing the efficacy of L-Ornithine-L-Aspartate (LOLA) infusion against lactose enemas in the treatment of acute hepatic encephalopathy.
详细描述
The main impact of hepatic encephalopathy in patients with cirrhosis is not related to costs, but its association with decreased survival and quality of life and should therefore clearly established the effectiveness of therapeutic interventions used in this disorder.
At the end of the nineteenth century to the ammonium was identified as the main agent responsible for the development of the syndrome of hepatic encephalopathy. Since then, reduced nitrogen compounds from the intestine are considered the main therapeutic measure. On this conceptual base, nonabsorbable disaccharides are the first line therapy in hepatic encephalopathy.
Current knowledge indicates that other organs such as muscle, brain and kidney are involved in the generation of ammonium, which has set the pace for the development of new treatments, able to act systemically in metabolism and elimination of ammonia . L-ornithine L-aspartate (LOLA) lowers ammonium concentrations in animal and humans models with hyperammonemia. There are no adequate clinical trials comparing the efficacy of LOLA infusion against lactose enemas in the treatment of acute hepatic encephalopathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis of any etiology, diagnosed by ultrasound,clinical and / or histologic criteria
- •Patients over 18 years and under 75
- •Patients with hepatic encephalopathy grade 3-4 according to the criteria of West Haven
- •Patients with hyperammonemia >10 µmol/l
排除标准
- •Evidence of neurological or psychiatric illness
- •Use of drugs affecting the central nervous system
- •Withdrawal Syndrome
- •Anorectal disease that interferes with the administration of enemas
研究组 & 干预措施
Intravenous infusion of L- Ornithine L- Aspartate
a) 20 g L-ornithine-L-aspartate
干预措施: L-ornithine-L-aspartate (Drug)
Lactose enemas
b) 20% Lactose enemas
干预措施: Lactose (Drug)
结局指标
主要结局
Improvement of at least one grade in mental state based on the West Haven Criteria
时间窗: 72 hours
Improvement was assessed at 0, 24, 48 and 72 hours. The mental state was scored from trivial lack of awareness to deep coma from grade 1 to grade 4.
次要结局
- Improvement of at least one grade in mental state assessed by the Glasgow Coma Scale(72 hours)
- Improvement of at least one grade in mental state assessed by the Clinical Hepatic Encephalopathy Staging Scale (CHESS)(72 hours)
- Improvement of asterixis grade(72 hours)
- Improvement in electroencephalographic tracing grade(72 hours)
- Improvement in serum ammonia(72 hours)
- Improvement in Number connection tests(72 hours)
- Improvement in Portosystemic Encephalopathy Index.(72 hours)
研究者
Dr. Claudia Isabel Blanco Vela
MD
Centro Regional para el Estudio de las Enfermedades Digestivas