Clinical trial NCT04022941: Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the blood ammonia levels at 5 days of starting therapy in both groups.
timeFrame: Day 5
Secondary outcomes:
measure: Change in the grading of Hepatic Encephalopathy in both groups.
timeFrame: Day 28
measure: Change in the grading of Hepatic Encephalopathy in both groups.
timeFrame: Day 90
measure: Proportion of children with worsening ascites in both groups.
timeFrame: Day 28
measure: Proportion of children with worsening ascites in both groups.
timeFrame: Day 90
measure: Proportion of children with hypernatremia in both groups.
timeFrame: Day 28
measure: Proportion of children with hypernatremia in both groups.
timeFrame: Day 90
measure: Proportion of children with metabolic acidosis in both groups.
timeFrame: Day 28
measure: Proportion of children with metabolic acidosis in both groups.
timeFrame: Day 90
measure: Duration of hospital stay in both groups.
timeFrame: Day 28
measure: Duration of hospital stay in both groups.
timeFrame: Day 90
measure: Short term survival with native liver in both groups
timeFrame: Day 28
measure: Short term survival with native liver in both groups
timeFrame: Day 90
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: