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

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver & Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium Benzoate
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.
Placebo Comparator: Placebo
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 13, 2019

First Posted (Actual)

July 17, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 13, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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