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.
Verified date | July 2019 |
Source | Institute of Liver and Biliary Sciences, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the blood ammonia levels at 5 days of starting therapy in both groups. | Day 5 | ||
Secondary | Change in the grading of Hepatic Encephalopathy in both groups. | Day 28 | ||
Secondary | Change in the grading of Hepatic Encephalopathy in both groups. | Day 90 | ||
Secondary | Proportion of children with worsening ascites in both groups. | Day 28 | ||
Secondary | Proportion of children with worsening ascites in both groups. | Day 90 | ||
Secondary | Proportion of children with hypernatremia in both groups. | Day 28 | ||
Secondary | Proportion of children with hypernatremia in both groups. | Day 90 | ||
Secondary | Proportion of children with metabolic acidosis in both groups. | Day 28 | ||
Secondary | Proportion of children with metabolic acidosis in both groups. | Day 90 | ||
Secondary | Duration of hospital stay in both groups. | Day 28 | ||
Secondary | Duration of hospital stay in both groups. | Day 90 | ||
Secondary | Short term survival with native liver in both groups | Day 28 | ||
Secondary | Short term survival with native liver in both groups | Day 90 |
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
|
||
Terminated |
NCT02530567 -
Non-invasive Evaluation of Portal Pressure by MRI
|
N/A | |
Suspended |
NCT02650011 -
Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
|
||
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 |