Role of Sodium Benzoate in the decreasing ammonia levels in children with chronic liver disease
Not Applicable
Completed
- Conditions
- Health Condition 1: K721- Chronic hepatic failure
- Registration Number
- CTRI/2017/08/009329
- Lead Sponsor
- Department of Pediatric Hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in the blood ammonia levels at 5 days of starting therapy.Timepoint: Day 5
- Secondary Outcome Measures
Name Time Method oChange in grade of HE from day 0 to day 5 for overt HE. <br/ ><br>oProportion of children with worsening ascites, hypernatremia and metabolic acidosis. <br/ ><br>oDuration of hospital stay. <br/ ><br>o Short term survival (28 days and 90 days) with native liverTimepoint: Day 28 and Day 90;SurvivalTimepoint: day 90