Back to resultsEfficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
Primary Purpose
Chronic Liver Disease
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sodium Benzoate
Powdered table sugar as palcebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Liver Disease
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:
- 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.
Sites / Locations
- Institute of Liver & Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium Benzoate
Placebo
Arm Description
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.
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.
Outcomes
Primary Outcome Measures
Change in the blood ammonia levels at 5 days of starting therapy in both groups.
Secondary Outcome Measures
Change in the grading of Hepatic Encephalopathy in both groups.
Change in the grading of Hepatic Encephalopathy in both groups.
Proportion of children with worsening ascites in both groups.
Proportion of children with worsening ascites in both groups.
Proportion of children with hypernatremia in both groups.
Proportion of children with hypernatremia in both groups.
Proportion of children with metabolic acidosis in both groups.
Proportion of children with metabolic acidosis in both groups.
Duration of hospital stay in both groups.
Duration of hospital stay in both groups.
Short term survival with native liver in both groups
Short term survival with native liver in both groups
Full Information
NCT ID
NCT04022941
First Posted
July 7, 2019
Last Updated
July 13, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT04022941
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Benzoate
Arm Type
Experimental
Arm Description
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium Benzoate
Intervention Description
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.
Intervention Type
Other
Intervention Name(s)
Powdered table sugar as palcebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the blood ammonia levels at 5 days of starting therapy in both groups.
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Change in the grading of Hepatic Encephalopathy in both groups.
Time Frame
Day 28
Title
Change in the grading of Hepatic Encephalopathy in both groups.
Time Frame
Day 90
Title
Proportion of children with worsening ascites in both groups.
Time Frame
Day 28
Title
Proportion of children with worsening ascites in both groups.
Time Frame
Day 90
Title
Proportion of children with hypernatremia in both groups.
Time Frame
Day 28
Title
Proportion of children with hypernatremia in both groups.
Time Frame
Day 90
Title
Proportion of children with metabolic acidosis in both groups.
Time Frame
Day 28
Title
Proportion of children with metabolic acidosis in both groups.
Time Frame
Day 90
Title
Duration of hospital stay in both groups.
Time Frame
Day 28
Title
Duration of hospital stay in both groups.
Time Frame
Day 90
Title
Short term survival with native liver in both groups
Time Frame
Day 28
Title
Short term survival with native liver in both groups
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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.
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
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