Clinical Trials Logo

Clinical Trial Summary

Clinically significant portal hypertension (CSPH) is defined as 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 (1). 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 (2). 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. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study


Clinical Trial Description

To assess whether Acute hemodynamic response to oral Carvedilol can predict short term outcome in ACLF patients. • To determine the best cut off to define acute hemodynamic response in ACLF patients Primary outcome - Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF Secondary outcome - (1) Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days (2) Transplant-free survival rate at 90 days (3) Correlation with evolution of AARC score by 2 week (b) Methodology Study population: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria Baseline parameters that will be recorded: 1. Baseline characteristics: 2. History and etiology of liver disease 3. Symptomatology, Evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc) 4. Clinical and demographic profile 5. Endoscopy Stopping rule of study: 1. Progression to exclusion criteria 2. In case of hypotension(<90/60mmHg) or Heart Rate <60 after carvedilol 3. Potential liver transplant within 90 days ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06298656
Study type Observational
Source Institute of Liver and Biliary Sciences, India
Contact Dr Garvit Mundra, MD
Phone 01146300000
Email garvitmundrailbs@gmail.com
Status Not yet recruiting
Phase
Start date March 10, 2024
Completion date February 28, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05985863 - Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT04822922 - Safety of UC-MSC Transfusion for ACLF Patients Phase 2
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Completed NCT04983108 - Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure
Withdrawn NCT05940610 - The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05019352 - Cytokine Adsorption in Acute-on-chronic Liver Failure N/A
Recruiting NCT05421351 - Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Completed NCT02321371 - Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy. N/A
Not yet recruiting NCT06069037 - SALT for Treatment of Patients With Early ACLF N/A
Completed NCT02965560 - Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Recruiting NCT03713489 - Platelet Transfusion in HBV-related acute-on Chronic Liver Failure N/A
Withdrawn NCT03629015 - Safety Study of Stemchymal® in Acute Liver Failure Phase 1
Recruiting NCT04621812 - Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Suspended NCT03737448 - TRimetazidine for acUte on Chronic Liver Failure STudy Phase 1
Recruiting NCT06128421 - Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk N/A
Recruiting NCT05700708 - Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Completed NCT04238416 - Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF Phase 1
Completed NCT03456518 - Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease