Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Chronic Liver Disease

Treatments: Other: Powdered table sugar as palcebo; Drug: Sodium Benzoate

Study type: Interventional

Funder types: Other

Identifiers

NCT04022941

ILBS-Cirrhosis-22

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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 priorto 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups, including a placebo group

Sodium Benzoate

Experimental group

Description:

Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.

Treatment:

Drug: Sodium Benzoate

Placebo

Placebo Comparator group

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.

Treatment:

Other: Powdered table sugar as palcebo