4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Tracking Information
First Submitted Date  ICMJE July 7, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2019) 		Change in the blood ammonia levels at 5 days of starting therapy in both groups. [ Time Frame: Day 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • Change in the grading of Hepatic Encephalopathy in both groups. [ Time Frame: Day 28 ]
  • Change in the grading of Hepatic Encephalopathy in both groups. [ Time Frame: Day 90 ]
  • Proportion of children with worsening ascites in both groups. [ Time Frame: Day 28 ]
  • Proportion of children with worsening ascites in both groups. [ Time Frame: Day 90 ]
  • Proportion of children with hypernatremia in both groups. [ Time Frame: Day 28 ]
  • Proportion of children with hypernatremia in both groups. [ Time Frame: Day 90 ]
  • Proportion of children with metabolic acidosis in both groups. [ Time Frame: Day 28 ]
  • Proportion of children with metabolic acidosis in both groups. [ Time Frame: Day 90 ]
  • Duration of hospital stay in both groups. [ Time Frame: Day 28 ]
  • Duration of hospital stay in both groups. [ Time Frame: Day 90 ]
  • Short term survival with native liver in both groups [ Time Frame: Day 28 ]
  • Short term survival with native liver in both groups [ Time Frame: Day 90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
Official Title  ICMJE Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescents With Chronic Liver Disese - A Randomised Controlled Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Liver Disease
Intervention  ICMJE
  • Drug: Sodium Benzoate
    Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.
  • 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.
Study Arms  ICMJE
  • Experimental: Sodium Benzoate
    Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5days.
    Intervention: Drug: Sodium Benzoate
  • 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.
    Intervention: Other: Powdered table sugar as palcebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2019) 		108
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022941
Other Study ID Numbers  ICMJE ILBS-Cirrhosis-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Liver and Biliary Sciences, India
Study Sponsor  ICMJE Institute of Liver and Biliary Sciences, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Liver and Biliary Sciences, India
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药