Response to Carvedilol (drug) in Children With Clinically Significant Portal Hypertension (Liver Disease)

Not Applicable

Conditions: Health Condition 1: K766- Portal hypertension

Registration Number: CTRI/2023/03/050334

Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.All children 2-18 years of age with CLD defined as presence of either of the following histological evidence of advanced fibrosis more than F2 on METAVIR staging or radiological imaging suggestive (heterogeneous hepatic echotexture, irregular nodular liver and/or caudate hypertrophy).

2.Splenomegaly and/or platelets less than equals to 100.

3.Coming for upper gastrointestinal endoscopy for variceal screening.

4.Informed consent for HVPG and UGIE

Exclusion Criteria

1.Uncorrected heart defects (except small ASD)

2.Cardiac conduction defects - arrythmias or heart block

3.Interrupted inferior vena cava

4.Situs inversus

5.Patients who received beta-blockers in last 7 days

6.Patients who received Octreotide infusion or bolus in last 7 days

7.Variceal bleed in last 48 hours

8.Shock or active sepsis

9.Grade 2 /grade 3 ascites

10.Severe hepatic impairment with MELD or PELD score >14

11.Acute kidney injury (any grade)

12.Hepatic encephalopathy (any grade)

13.Known contraindications to propranolol in children:

14.Hyper-reactive airway disease

15.Hypertrophic cardiomyopathy

16.Acute congestive heart failure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the proportion of children (2-18year age) with acute hemodynamic <br/ ><br>response (HVPG reduction to less than 12 mm Hg or by more than equals to 20% from initial value 90 mins after carvedilol given through nasogastric route) in those with clinicallysignificant portal hypertension (HVPG more than equals to 20 mm Hg).Timepoint: 90 minutes

Secondary Outcome Measures

Name	Time	Method
To compare the Bile acid levels in children with HVPG more than equal to 10 or less than 10 mm Hg in different etiologies of liver disease.Timepoint: Day 0;To compare the HVPG values in children (2-18 years age) with different etiologies of chronic liver diseaseTimepoint: Day 0;To compare the proportion of children with presence of varices and clinically significant varices in children with HVPG more than equal to 10 or less than 10 mm Hg in different etiologies of liver diseaseTimepoint: Day 0;To compare the Splenic Z-scores, Liver and splenic stiffness in children with HVPG more than equal to 10 or less than 10 mm Hg in different etiologies of liver diseaseTimepoint: Day 0;To study the change in endoscopic findings 6 months after starting oral <br/ ><br>carvedilol in children with or without acute hemodynamic response.Timepoint: 6 months;To study the predictors of acute hemodynamic response on univariate and <br/ ><br>multivariate binary logistic regression analysis.Timepoint: Day 0