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Completed

NCT Number: NCT04022941

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

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.

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Key information

Conditions

Chronic Liver Disease

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Benzoate

Drug

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

Powdered table sugar as palcebo

Other

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.

Primary outcomes

  1. Change in the blood ammonia levels at 5 days of starting therapy in both groups.

    Time frame: Day 5

Secondary outcomes

  1. Change in the grading of Hepatic Encephalopathy in both groups.

    Time frame: Day 28

  2. Change in the grading of Hepatic Encephalopathy in both groups.

    Time frame: Day 90

  3. Proportion of children with worsening ascites in both groups.

    Time frame: Day 28

  4. Proportion of children with worsening ascites in both groups.

    Time frame: Day 90

  5. Proportion of children with hypernatremia in both groups.

    Time frame: Day 28

  6. Proportion of children with hypernatremia in both groups.

    Time frame: Day 90

  7. Proportion of children with metabolic acidosis in both groups.

    Time frame: Day 28

  8. Proportion of children with metabolic acidosis in both groups.

    Time frame: Day 90

  9. Duration of hospital stay in both groups.

    Time frame: Day 28

  10. Duration of hospital stay in both groups.

    Time frame: Day 90

  11. Short term survival with native liver in both groups

    Time frame: Day 28

  12. Short term survival with native liver in both groups

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescents With Chronic Liver Disese - A Randomised Controlled Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 17, 2019
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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