NCT06344611

Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or 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 period:2 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 plan/investigatios (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; Monocyte/Basophil Frequency, NLR; CRP, Procalcitonin) and Intestinal Inflammation (Stool cytokines- IL-6, TNFα, IL-1β, IL-10)

Conditions

• Decompensated Cirrhosis

Interventions

Type	Name	Description
OTHER	Other	It is an observational study. Subjects will receive the treatment as per institute protocol.

Timeline

• Start date: 2024-04-07
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-04-03
• Last updated: 2024-04-03

Locations

1 site across 1 country: India