Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344611
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-27
Brief Title:
Incidence Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Incidence Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive andor chronic liver injury due to toxic infectious metabolic and genetic pathogenic factors Traditionally the natural history of cirrhosis has often been considered a one-way street with a definite and irreversible progression from a compensated to a decompensated disease stage But recent data has shown that if the underlying etiology can be successfully treated cirrhosis can regress and recompensation of liver disease can occur Hence in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase DCLD subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis
Detailed Description:
Aim- To evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria Primary objective To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria
Secondary objectives
1 To evaluate the predictive factors of recompensation in pediatric DCLD subjects
2 To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis
3 To assess incidence of re-decompensation in patients with recompensation Study design Prospective Observational study Study period2 years Aug 2023-Jul2025 Sample size Time bound All decompensated cirrhosis cases presenting to the institute during the study period will be included in the study
Intervention None since it is an observational study only
Monitoring and assessment
Along with standard tratment planinvestigatios as per etiology Liver function test INR and Ultrasound abdomen would be done at 3 monthly interval
At baseline Markers of Systemic Inflammation serum levels of IL-6 TNFα IL-1β MonocyteBasophil Frequency NLR CRP Procalcitonin and Intestinal Inflammation Stool cytokines- IL-6 TNFα IL-1β IL-10
Secondary objectives
1 To evaluate the predictive factors of recompensation in pediatric DCLD subjects
2 To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis
3 To assess incidence of re-decompensation in patients with recompensation Study design Prospective Observational study Study period2 years Aug 2023-Jul2025 Sample size Time bound All decompensated cirrhosis cases presenting to the institute during the study period will be included in the study
Intervention None since it is an observational study only
Monitoring and assessment
Along with standard tratment planinvestigatios as per etiology Liver function test INR and Ultrasound abdomen would be done at 3 monthly interval
At baseline Markers of Systemic Inflammation serum levels of IL-6 TNFα IL-1β MonocyteBasophil Frequency NLR CRP Procalcitonin and Intestinal Inflammation Stool cytokines- IL-6 TNFα IL-1β IL-10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None