View clinical trials related to Liver Cirrhosis.
Filter by:The purpose is to investigate the effect of fecal microbiota transplantation (FMT)on complications, progression, and mortality of cirrhosis. Further, the investigators want to examine the impact of FMT on gut barrier function, systemic inflammation, and immune responses.
Fontan operation is currently the most common procedure performed in patients with single-ventricle physiology. This surgery allows for passive caval blood flow to the pulmonary arteries in the absence of a subpulmonary pump and therefore separating the pulmonary circulation from systemic circulation. However, late hepatic complications such as liver fibrosis, cirrhosis, or even hepatocellular carcinoma are increasingly described in patients with Fontan circulation. The Fontan associated liver disease (FALD) is related to the decreased cardiac output and elevated central venous pressure after Fontan operation. Although the prevalence of FALD is higher than 90% in patients with Fontan circulation. There are no specific medications can reverse the liver fibrosis or prevent the progression of FALD at present. Sildenafil had been used in patients after Fontan operation not only to decrease their pulmonary vascular resistance and central venous pressure, increased systemic cardiac output. Comparing with other oral pulmonary vasodilators, sildenafil is with less possibility of liver toxicity. Therefore, we will conduct a prospective, open-labeled, randomized-controlled study in at least 90 Fontan patients with age > 12 years receiving follow -up at our institute. These patients will be in accordance with the ratio of 1: 1 distribution randomized into two groups, group 1 will receive sildenafil 20 mg three times daily for 3 years and the group will not receive any pulmonary vasodilator as a control. Patients in both group will receive the examinations of liver fibrosis markers, transient ultrasound elastography (FibroScan), diffusion-weighted magnetic resonance imaging (DW-MRI) and cardiopulmonary function test at baseline, 1 year, 2 years and 3 years after initiating treatment. Comparing the results of two groups, we may further clarify the treatment effect of sildenafil on FALD in patients after Fontan procedure.
The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B). The enrolled participants receive a prophylactic single oral dose of either rivaroxaban (10 mg) or apixaban (2.5 mg) at around 8 a.m. on the day of the trial. Blood samples are taken 0.5 hours pre-dose and 1, 2, 3, 4, 6, 8, 12 hours post-dose. A follow-up telephone call is performed 5 days after the study intervention to collect safety data.
This is a phase II pilot study designed to assess the safety and efficacy of danazol for treatment of cytopenias in patients with CPC A/B cirrhosis. Subjects with or without telomere mutations and/or shortened telomeres will be treated with danazol 600 mg per day by mouth for a duration of 24 months. The goal will be to treat a total of 10 patients.
The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and elevated azygos flow. End-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic collaterals that shunt blood away from the liver develop due to increased portal pressure. Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal internal bleeding. GEV bleeding carries ~20% mortality at 6 weeks, and ~34% overall mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%. However, endoscopy is invasive and often unnecessary when no treatment is required. Therefore, the American Association for the Study of Liver Diseases has identified the development of "non-invasive markers that predict the presence of high-risk varices" as a major unmet need.
Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.
Septic shock is a major life-threatening vasodilatory shock. Vasopressor form a crucial pharmacotherapeutic option and have long been used as the first and foremost recommended therapy.(1) However, some patients may remain refractory to catecholamine, which is also known as catecholamine-resistant septic shock.(2, 3) High-dose catecholamine therapy may lead to potential side effects such as increased myocardial oxygen consumption, lethal arrthymias, and even the high risk of mortality. (4)Therefore, newer alternatives like dopamine, dobutamine, somatostatin, and terlipressin are also used. Cirrhosis is a state of hyperdynamic circulation, which worsens with the onset of infection. In septic shock, there is relative deficiency of vasopressin. (13) The mortality of septic shock in these patients still remains extremely high. Terlipressin is a synthetic vasopressin analogue with greater selectivity for the V1-receptors.(5) In cirrhotics with septic shock, terlipressin has been used either as a continuous intravenous infusion or as intravenous boluses. However, at present none of studies reveal which would be a better mode of administration in cirrhotics with septic shock considering the reversal of hemodynamics and safety of patients.
The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis. Cirrhosis is a leading cause of disability and mortality worldwide. Cirrhosis occurs in 50% of patients over 10 years. Decompensated cirrhosis carries a poor prognosis because the median survival time is about 2 years and it imposes a heavy burden on health care costs mainly due to the need for repeated hospital admission. The mortality is approximately 40% at 1 year and 50% at 2 years (12.7 per 100,000 population). A lot of times the prognosis is poor and the main factors leading to it are - AKI/HRS-NAKI, Hyponatremia, Grade of ascites-Refractory ascites, Sarcopenia, low Mean arterial pressure. Post review of the literature, it is realized that there are some gap areas - - It is unknown whether combination of vasoconstrictor with albumin further decreases the need for paracentesis in patients of refractory ascites. - There are no studies till date on using combination of vasoconstrictor with albumin for refractory ascites. - There are no studies evaluating the prevalence and incidence of HRS-NAKI using the new definitions in patients with refractory ascites and impact of combining vasoconstrictor and albumin in improving renal outcomes in these patients.
This will be a randomized study on the effects of hypothermic oxygenated machine perfusion in patients undergoing liver transplantations from donors after brain death with allocation of patients to either end-ischemic hypothermic oxygenated machine perfusion group (at least 2 hours of allograft perfusion at 12 degrees Celsius though hepatic artery and portal vein prior to implantation) or simple cold storage group in a 1:3 ratio. The primary outcome measure of the study will be model for early graft dysfunction (MEAF) score. A total number of 104 patients, including 26 in the hypothermic perfusion group and 78 in simple cold storage group will be included. Data on potential risk factors for worse allograft function and increased ischemia-reperfusion injury will be collected perioperatively. Circulating levels of proinflammatory cytokines (IL-2, IL-10, TNFα), nuclear damage (HMGB-1, 8-OHdG), serum activity of transaminases, gamma-glutamyl-transpeptidase, bilirubin concentration, and INR will be assessed in the perioperative period. Wedge allograft biopsies will be performed 90 minutes post-reperfusion to evaluate activation of innate immunity (TLR4), activation of endothelium (vWF, P-selectin), hepatocyte necrosis, hepatocyte apoptosis (TUNEL assay), ATP content, and oxidative damage (malondialdehyde content). Further, wedge biopsies will be performed at the end of simple cold storage and at the beginning and after two hours of perfusion to determine steatosis and ATP content. During the perfusion, perfusate samples will be periodically tested for lactate, sodium, and potassium concentration, CO2 partiall pressure, and flavin mononucleotide concentration. Patients will be closely monitored in the postoperative period for allograft function and secondary end-points: 2-year recipient and graft survival, 2-year incidence of biliary complications, and 90-day complication rate. Both groups will be compared with respect to the primary and secondary end-points, circulating levels of IL-2, IL-10, TNFα, HMGB-1, 8-OHdG, activity of transaminases and gamma-glutamyl-transpeptidase, and findings in post-reperfusion allograft biopsies. Further, changes of hepatic steatosis and hepatic ATP content during perfusion will be evaluated, and the results of perfusate analyses will be tested as predictors of allograft function in the post-transplant period.