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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022941
• Other study ID #: ILBS-Cirrhosis-22
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Hyperammonemia
• Liver Diseases

Intervention

Drug:
• Sodium Benzoate
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.

Other:
• Powdered 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.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the blood ammonia levels at 5 days of starting therapy in both groups.		Day 5
Secondary	Change in the grading of Hepatic Encephalopathy in both groups.		Day 28
Secondary	Change in the grading of Hepatic Encephalopathy in both groups.		Day 90
Secondary	Proportion of children with worsening ascites in both groups.		Day 28
Secondary	Proportion of children with worsening ascites in both groups.		Day 90
Secondary	Proportion of children with hypernatremia in both groups.		Day 28
Secondary	Proportion of children with hypernatremia in both groups.		Day 90
Secondary	Proportion of children with metabolic acidosis in both groups.		Day 28
Secondary	Proportion of children with metabolic acidosis in both groups.		Day 90
Secondary	Duration of hospital stay in both groups.		Day 28
Secondary	Duration of hospital stay in both groups.		Day 90
Secondary	Short term survival with native liver in both groups		Day 28
Secondary	Short term survival with native liver in both groups		Day 90