Chronic Liver Disease
Conditions
Brief summary
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.
Interventions
DRUGSodium Benzoate
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.
OTHERPowdered table sugar as palcebo
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.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
\- Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia \< 400 mcgm and /dl.
Exclusion criteria
1. Patients who have received sodium benzoate within 1 week priorto evaluation. 2. Baseline serum sodium above 155 mEq/L 3. Patients with Grade 3 ascites as per IAC classification. 4. Patients who did not give a written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the blood ammonia levels at 5 days of starting therapy in both groups. | Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of children with worsening ascites in both groups. | Day 28 |
| Proportion of children with hypernatremia in both groups. | Day 28 |
| Change in the grading of Hepatic Encephalopathy in both groups. | Day 28 |
| Duration of hospital stay in both groups. | Day 28 |
| Short term survival with native liver in both groups | Day 28 |
| Proportion of children with metabolic acidosis in both groups. | Day 28 |
Countries
India
Outcome results
None listed