Chronic Liver Disease Clinical Trial
Official title:
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescents With Chronic Liver Disese - A Randomised Controlled Trial.
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.
n/a
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