- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04022941
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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.
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-Cirrhosis-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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