Acute Hemodynamic Response to Carvedilol in Children With Clinically Significant Portal Hypertension.

• Status: Not yet recruiting
• Trial end date: 2025-02-14
• Target enrollment: 0
• Participant gender: All

Summary

Clinically significant portal hypertension (CSPH) is defined as Hepatic Venous Pressure gradient (HVPG) >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality. HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers. Non-selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to < 12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long-term risk of variceal bleed. Portal Hypertension in biliary atresia (BA) occurs early and is due to recurrent cholangitis and portal sclerosis. HVPG in children is feasible and safe in children according to previous studies, however, there are no recommendations to suggest beta-blockers based on HVPG reduction in children. Hence, we are planning the current work to study the acute hemodynamic response to carvedilol in children with CSPH, and to compare the HVPG values in children with chronic liver disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• 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). .

• Splenomegaly and/or platelets
• Coming for upper gastrointestinal endoscopy for variceal screening

• Informed consent for HVPG and UGIE

Exclusion Criteria:

• Uncorrected heart defects (except small ASD)

• Cardiac conduction defects - arrythmias or heart block

• Interrupted inferior vena cava

• Situs inversus

• Patients who received beta-blockers in last 7 days

• Patients who received Octreotide infusion or bolus in last 7 days

• Variceal bleed in last 48 hours

• Shock or active sepsis

• Grade 2 /grade 3 ascites

• Severe hepatic impairment with MELD or PELD score >14

• Acute kidney injury (any grade)

• Hepatic encephalopathy (any grade)

• Known contraindications to propranolol in children:

• Hyper-reactive airway disease

• Hypertrophic cardiomyopathy

• Acute congestive heart failure