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

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ClinicalTrials.gov Identifier: NCT04022941
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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/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.


Condition or disease Intervention/treatment Phase
Chronic Liver Disease Drug: Sodium Benzoate Other: Powdered table sugar as palcebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Experimental: Sodium Benzoate
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.
Drug: Sodium Benzoate
Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.

Placebo Comparator: Placebo
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.
Other: Powdered table sugar as palcebo
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 Outcome Measures :
  1. Change in the blood ammonia levels at 5 days of starting therapy in both groups. [ Time Frame: Day 5 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022941


Locations
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India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT04022941     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-22
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Hyperammonemia
Digestive System Diseases
Pathologic Processes
Sodium Benzoate
Antifungal Agents
Anti-Infective Agents