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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.
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.
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Change in the blood ammonia levels at 5 days of starting therapy in both groups.
Time frame: Day 5
Change in the grading of Hepatic Encephalopathy in both groups.
Time frame: Day 28
Change in the grading of Hepatic Encephalopathy in both groups.
Time frame: Day 90
Proportion of children with worsening ascites in both groups.
Time frame: Day 28
Proportion of children with worsening ascites in both groups.
Time frame: Day 90
Proportion of children with hypernatremia in both groups.
Time frame: Day 28
Proportion of children with hypernatremia in both groups.
Time frame: Day 90
Proportion of children with metabolic acidosis in both groups.
Time frame: Day 28
Proportion of children with metabolic acidosis in both groups.
Time frame: Day 90
Duration of hospital stay in both groups.
Time frame: Day 28
Duration of hospital stay in both groups.
Time frame: Day 90
Short term survival with native liver in both groups
Time frame: Day 28
Short term survival with native liver in both groups
Time frame: Day 90
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