Status:
COMPLETED
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Chronic Liver Disease
Eligibility:
All Genders
1-18 years
Phase:
NA
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/K...
Eligibility Criteria
Inclusion
- \- Infants, children and adolescents under 18 years of age with decompensated Chronic liver disease with hyperammonemia \< 400 mcgm and /dl.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04022941
Start Date
April 1 2017
End Date
December 31 2018
Last Update
July 17 2019
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070