Decompensated Cirrhosis of Liver

The goal of this clinical trial is to determine primarily whether a combinatorial therapy based on the administration of human albumin and enoxaparin is safe and effective in patients with decompensated cirrhosis discharged from the hospital. The main questions it aims to answer are: * Is this combinatorial therapy safe and tolerable? * Is this combinatorial therapy effective? * does this combinatorial therapy cost more or less than standard medical therapy? Participants will attend to study visits in which several test will be performed to asses disease evolution while they are taking study medication. Researchers will compare experimental group treated with combinatorial therapy plus standard treatment with control group treated with standard treatment to see if there are differences in the responses to the questions raised above.

Cirrhosis, a leading cause of global mortality, progresses to life-threatening complications like ascites, hepatic encephalopathy, and hepatorenal syndrome. Oxidative stress and gut-liver axis dysfunction drive disease progression. Allopurinol, a xanthine oxidase inhibitor, has shown potential in reducing complications in cirrhosis, but robust clinical evidence is lacking. This study will evaluate allopurinol's efficacy in preventing complications in decompensated cirrhosis. This study aims to assess whether allopurinol reduces cirrhosis-related complications (ascites, variceal bleeding, hepatic encephalopathy, SBP, HRS-AKI) and improves MELD/CTP scores in Child-Pugh B/C cirrhosis patients. This study will select 54 patients with decompensated cirrhosis (Child-Pugh B/C). Patients aged 18-70 years, with any etiology of cirrhosis (viral, alcoholic, NAFLD). Patients with acute decompensation, allopurinol hypersensitivity, advanced renal impairment (CrCl \<30 mL/min), pregnancy, or concurrent use of interacting drugs. This randomized controlled trial will be conducted in Hepatology department of BMU after IRB clearance. 54 patients aged 18 to 70 years with Child-Pugh class B or C cirrhosis, admitted to or attending the Outpatient Department of Hepatology at Bangladesh Medical University will be enrolled. After thorough clinical and laboratory evaluation and informed consent, patients will be randomized in a either an allopurinol treatment group or a standard care group with placebo ; 27 participants in each group by block randomization. one group will receive oral Allopurinol (titrated from 100 mg to 300 mg daily for six months) along with standard medical therapy. Another Group will receive same dose of Placebo along with standard medical therapy . Patients will be followed at 6 month to see the progression of cirrhosis-related complications. Data collection will include clinical parameters, laboratory tests, imaging, and endoscopy. All data will be analyzed using the statistical package SPSS (version 29.0 IBM Corp: Armonk NY, USA). Demographic and baseline clinical characteristics will be analyzed using the chi-square test for categorical variables. For continuous variables that follow a normal distribution, the Student's t-test will be applied. Time to first complication will be analyzed using the Cox proportional hazards model, and Kaplan-Meier curves will be used to compare event-free survival between groups. The study protocol is approved by the institutional review board. Written informed consent (Bengali version) will be obtained, ensuring confidentiality and voluntary participation. Participants may withdraw anytime. If effective, allopurinol will offer a low-cost, widely accessible therapy to prevent complications and improve survival in decompensated cirrhosis. To the best of my knowledge this is the first study in Bangladesh to evaluate the efficacy of Allopurinol in prevention of cirrhosis associated complications.

This study tests whether a medication called droxidopa can help improve blood flow to the kidneys in people with liver cirrhosis who develop kidney problems while in the hospital. When someone with cirrhosis experiences kidney injury, having better blood pressure can help their kidneys recover. Droxidopa is an oral medication that may help raise blood pressure without requiring intensive care or invasive treatments. The study will compare droxidopa to a placebo (inactive pill) in 75 people hospitalized with cirrhosis and kidney injury. Participants will take either droxidopa or placebo pills for 28 days and be monitored for an additional 30 days. Researchers will measure changes in blood pressure and kidney function to determine if droxidopa is effective and safe for these patients. This research could identify a new treatment option for a serious complication of liver disease.

The goal of this clinical trial is to learn if an integrated digital and telemedicine care model works to manage decompensated cirrhosis in patients. It will also learn about the impact of this model on healthcare resource consumption and patient quality of life. The main questions it aims to answer are: 1. Does this telemedicine model lower the number of cirrhosis-related hospitalizations and emergency department visits? 2. Does the model reduce medical expenses and improve disease outcomes compared to standard care? Researchers will compare the digital telemedicine care model (utilizing the NTUH-TPC platform and wearable devices) to standard health care to see if the digital approach effectively reduces hospital admissions and medical costs. Participants will: 1. Use the NTUH telehealth platform (NTUH-TPC) to access records and upload physiological, medical, and imaging data. 2. Wear a smart watch for remote physiological monitoring. Receive continuous remote care and proactive follow-ups from case managers.

Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.