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Role of Sodium Benzoate in the decreasing ammonia levels in children with chronic liver disease

Efficacy and safety of sodium benzoate in the management of hyperammonemia in infants, children and adoloscents with Chronic liver disese - Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009329
Enrollment
198
Registered
2017-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K721- Chronic hepatic failure

Interventions

Intervention1: Group A: Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.Since the dosage of Sodium Benzoate is Stat 250mg/Kg and then 250mg

Sponsors

Department of Pediatric Hepatology
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria: 1. Patients who have received sodium benzoate within 1 week prior to 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.

Design outcomes

Primary

MeasureTime frame
The change in the blood ammonia levels at 5 days of starting therapy.Timepoint: Day 5

Secondary

MeasureTime frame
o Change in grade of HE from day 0 to day 5 for overt HE. o Proportion of children with worsening ascites, hypernatremia and metabolic acidosis. o Duration of hospital stay. o Short term survival (28 days and 90 days) with native liverTimepoint: Day 28 and Day 90;SurvivalTimepoint: day 90

Countries

India

Contacts

Public ContactSnehavardhan Pandey

Institute of Liver and Biliary Sciences, New Delhi

seema_alam@hotmail.com9540951008

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026