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

NCT04022941 | Completed

• 1 other identifier: ILBS-Cirrhosis-22
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Change in the blood ammonia levels at 5 days of starting therapy in both groups.

  Day 5

Secondary Outcomes (12)

• 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

Study Arms (2)

Sodium Benzoate

EXPERIMENTAL

Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.

Drug: Sodium Benzoate

Placebo

PLACEBO COMPARATOR

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

Interventions

Sodium Benzoate DRUG

Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.

Sodium Benzoate

Powdered table sugar as palcebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia \< 400 mcgm and /dl.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Sodium Benzoate

Intervention Hierarchy (Ancestors)

Benzoic Acid; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 17, 2019
• Study Start: April 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

IN (1)