Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescents With Chronic Liver Disese - A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in the blood ammonia levels at 5 days of starting therapy in both groups.
研究概览
简要总结
Subject will be randomize in two groups. Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.Since the dosage of Sodium Benzoate is Sta t250mg/Kg and then 250mg/Kg in next 24 hours, each patient would be given 750mg /kg stat and 750mg /kg in next 24 hours,keeping in view that 2/3 of powder used would be powdered sugar in the intervention arm. The dose of the powder used would be doubled in case of the ammonia level more than 300 mcg/dl. The drug will be prepared in sterile water and administered per orally or via the nasogastric tube. All the enrolled patients would be treated with SMT as per the recommendations of the EASL/AASLD 2014 guidelines of management of hepatic encephalopathy.
Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
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, Investigator)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia < 400 mcgm and /dl.
排除标准
- •Patients who have received sodium benzoate within 1 week priorto evaluation.
- •Baseline serum sodium above 155 mEq/L
- •Patients with Grade 3 ascites as per IAC classification.
- •Patients who did not give a written informed consent.
研究组 & 干预措施
Sodium Benzoate
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.
干预措施: Sodium Benzoate (Drug)
Placebo
Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
干预措施: Powdered table sugar as palcebo (Other)
结局指标
主要结局
Change in the blood ammonia levels at 5 days of starting therapy in both groups.
时间窗: Day 5
次要结局
- Proportion of children with worsening ascites in both groups.(Day 90)
- Proportion of children with metabolic acidosis in both groups.(Day 90)
- Proportion of children with hypernatremia in both groups.(Day 90)
- Duration of hospital stay in both groups.(Day 90)
- Short term survival with native liver in both groups(Day 90)
- Change in the grading of Hepatic Encephalopathy in both groups.(Day 90)