Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescents With Chronic Liver Disese - A Randomised Controlled Trial.

Conditions
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Chronic Liver Disease

Intervention / Treatment
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* Drug: Sodium Benzoate
* Other: Powdered table sugar as palcebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia < 400 mcgm and /dl. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Benzoate<br>Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days. | Drug: Sodium Benzoate<br>* Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.<br>|
| Placebo Comparator: Placebo<br>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. | Other: Powdered table sugar as palcebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the blood ammonia levels at 5 days of starting therapy in both groups. |  | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the grading of Hepatic Encephalopathy in both groups. |  | Day 28 | 
| Change in the grading of Hepatic Encephalopathy in both groups. |  | Day 90 | 
| Proportion of children with worsening ascites in both groups. |  | Day 28 | 
| Proportion of children with worsening ascites in both groups. |  | Day 90 | 
| Proportion of children with hypernatremia in both groups. |  | Day 28 | 
| Proportion of children with hypernatremia in both groups. |  | Day 90 | 
| Proportion of children with metabolic acidosis in both groups. |  | Day 28 | 
| Proportion of children with metabolic acidosis in both groups. |  | Day 90 | 
| Duration of hospital stay in both groups. |  | Day 28 | 
| Duration of hospital stay in both groups. |  | Day 90 | 
| Short term survival with native liver in both groups |  | Day 28 | 
| Short term survival with native liver in both groups |  | Day 90 |