Clinical Trials Logo
  1. Home
  2. Chronic Liver Disease
  3. NCT04022941

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

Chronic Liver Disease Clinical Trial

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.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04022941
Study type Interventional
Source Institute of Liver and Biliary Sciences, India
Contact
Status Completed
Phase N/A
Start date April 1, 2017
Completion date December 31, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03704792 - Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference N/A
Terminated NCT02949375 - Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease Phase 2
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT00756171 - Colesevelam Versus Placebo in Cholestatic Pruritus Phase 2/Phase 3
Completed NCT01195181 - Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice. Phase 4
Completed NCT05044663 - Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in NASH Related Compensated Advanced Chronic Liver Disease.
Recruiting NCT04588077 - Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis Phase 4
Recruiting NCT04802954 - Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients N/A
Recruiting NCT04622449 - Etiopathogenesis of Anemia in Chronic Liver Disease
Enrolling by invitation NCT05836246 - The Development of Quantitative Ultrasound Imaging Software Platform
Completed NCT03087344 - Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis N/A
Completed NCT04751045 - Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies N/A
Not yet recruiting NCT04526548 - A Diagnostic Study on Patients With Drug-induced Liver Injury
Withdrawn NCT02899325 - FDGal PET/CT to Detect Hepatocellular Carcinoma
Suspended NCT02650011 - Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
Terminated NCT02530567 - Non-invasive Evaluation of Portal Pressure by MRI N/A
Completed NCT01851252 - MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy Phase 1
Terminated NCT01756690 - Predicting Lung Injury From Transfusion in Patients With Liver Disease N/A
Completed NCT01600105 - Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI) Phase 4
Completed NCT01008293 - Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life Phase 2/Phase 3