Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluating the efficacy of nifuroxazide in improving mental status by calculating CHESS score
研究概览
简要总结
This is a pilot study designed to evaluate the efficacy and safety of nifuroxazide in the treatment of hepatic encephalopathy in patients with grade II-III hepatic encephalopathy
详细描述
Hepatic Encephalopathy (HE) is a central nervous system dysfunction caused by liver insufficiency and/or portosystemic shunting, manifesting as a wide spectrum of neurological or psychiatric abnormalities characterized by alteration of cognitive and motor function.
The pathogenesis of hepatic encephalopathy is believed to be due to increased nitrogenous substances, primarily ammonia, in the blood. The treatment goal is to reduce nitrogen load from the GI tract and to improve central nervous system (CNS) status.
Treatment options include lactulose administered orally and non-absorbable antibiotics.
Lactulose is nonabsorbable disaccharides that is currently used as first line agents for the treatment of HE. Its action is thought to be due to Colonic metabolism of lactulose to lactic acid results in acidification of the gut lumen. This favors conversion of ammonium (NH4) to ammonia (NH3) and the passage of ammonia from tissues into the lumen. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Lactulose also works as a cathartic, reducing colonic bacterial load.
Nifuroxazide is an oral broad-spectrum nitrofuran antibiotic that is commonly used as an intestinal anti-infective agent. It is active against the majority of intestinal bacteria: Gram-positive (Staphylococcus family) and Gram-negative (Enterobacteriaceae family: Escherichia, Citrobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Yersinia) and is therefore expected to decrease ammonia production and to reverse the symptoms of HE.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from liver cirrhosis aging above 18 years who will be admitted to hospital with neuropsychiatric condition suggestive of hepatic encephalopathy (grade II or III) confirmed by their known previous hepatic disease by history, clinical examination and laboratory investigations in the form of hyperammonemia with Model for End-Stage Liver Disease (MELD) score ≤ 25 and patients are able to swallow.
排除标准
- •Patients with neurological or communication problems.
- •Degenerative central nervous system (CNS) disease.
- •Any significant psychiatric illness.
- •Patients with previous intake of nifuroxazide and rifaximin within the last month.
- •Presence of underlying renal impairment (serum creatinine ≥ 2 mg/dL).
- •Alcohol consumption within prior 4 weeks.
- •Non-hepatic metabolic encephalopathy.
- •Anemia with hemoglobin level < 7 g/dL.
研究组 & 干预措施
lactulose plus Rifaximin plus nifuroxazide
Nifuroxazide dosing : 800 mg daily in 4 divided doses for 7 days Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.
Rifaximin: 550 mg twice daily
干预措施: Nifuroxazide (Drug)
lactulose plus Rifaximin plus nifuroxazide
Nifuroxazide dosing : 800 mg daily in 4 divided doses for 7 days Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.
Rifaximin: 550 mg twice daily
干预措施: Lactulose (Drug)
lactulose plus Rifaximin plus nifuroxazide
Nifuroxazide dosing : 800 mg daily in 4 divided doses for 7 days Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.
Rifaximin: 550 mg twice daily
干预措施: Rifaximin 550Mg Tab (Drug)
Lactulose plus Rifaximin
Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.
Rifaximin: 550 mg twice daily
干预措施: Lactulose (Drug)
Lactulose plus Rifaximin
Lactulose dosing : 30 to 60 mL PO TID to produce 2 to 3 semisoft stools per day.
Rifaximin: 550 mg twice daily
干预措施: Rifaximin 550Mg Tab (Drug)
结局指标
主要结局
Evaluating the efficacy of nifuroxazide in improving mental status by calculating CHESS score
时间窗: 7 days
Evaluating the efficacy by measuring serum ammonia at baseline and at end of treatment and calculating (CHESS) score at baseline and at end of treatment.
The time for complete reversal of HE
时间窗: 7 days
Number of patients achieving complete reversal of hepatic encephalopathy
时间窗: 7 days
Complete reversal is defined as the reversibility of HE from grade 2 or 3 to grade 0 or 1 according to West Haven criteria
次要结局
- Number of patients transferred to ICU(7 days)
- Length of hospital stay(7 days)
- the rate of adverse events occurring during the treatment(Maximum 7 days)
研究者
Mennat Allah Saeid Emam
Teaching assistant
Future University in Egypt