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62 active trials for Cirrhosis, Liver

Prophylactic Antibiotics in Admitted Cirrhotics

In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. Specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics vs placebo.

Start: August 2020

Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis

This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.

Start: August 2020

ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement

ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

Start: June 2019

Case-Control Study of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

Clinical guidelines (AASLD) recommend the use of abdominal ultrasound (US) for surveillance testing for the early detection of Hepatocellular Carcinoma (HCC). The serum protein biomarker alpha-fetoprotein (AFP) is commonly used to augment US but its use alone is not recommended by clinical guidelines. Despite evidence that HCC surveillance improves early detection and reduces mortality from HCC, current HCC surveillance tests lack sensitivity, leaving a significant proportion of patients to present with late-stage disease. The Glycotest HCC Panel has shown better sensitivity than AFP, which is ineffective for the detection of early-stage HCC. This clinical study seeks to validate the Glycotest HCC Panel using a large multicenter cohort of cases and controls that includes patients diagnosed with early-stage HCC against a background of cirrhosis and cirrhotic patients without HCC (at risk) undergoing an established surveillance protocol.

Start: May 2019

Shear Wave Elastography

In individuals needing a left ventricular assist device (LVAD), right heart failure (RHF) is a serious complication post-surgery, associated with worsened outcomes including mortality. However, predictors of decompensation after LVAD are not well established. Liver dysfunction pre-LVAD has been shown to be associated with poor outcomes post-LVAD, but the interplay between liver abnormalities and RHF post-LVAD is not well characterized. Liver stiffness (LS) is a measure associated with certain types of liver abnormalities (e.g., liver fibrosis; cirrhosis). Thus, we hypothesize that elevated LS measured by SWE is associated with increased morbidity and mortality in patients undergoing LVAD implantation and yields increased need for advanced postoperative HF therapies including the use of right ventricular assist devices (RVAD) for the management of RHF.

Start: May 2018

The Relationship Betweensarcopenia And Myosteatosis With The Natural History Of Liver Cirrhosis

Malnutrition is a common figure associated with liver cirrhosis. The main component of malnutrition in liver cirrhosis is represented by sarcopenia, a condition of a progressive and generalized loss of muscle mass and strength. Many studies have reported that sarcopenia is an independent predictor of morbidity and mortality in cirrhotic patients. Moreover, cirrhotic patients may develop simultaneous loss of skeletal muscle and gain of adipose tissue, culminating in a condition of "sarcopenic obesity". As highlighted by a recent systematic review and meta-analysis [Van Vgut 2017] all the studies on the impact of sarcopenia/sarcopenic obesity and myosteatosis in cirrhotic patients are retrospective studies, mostly involving non-consecutive patients on the list for liver transplantation. Moreover, most of the studies were produced by non-European centers (Canadians,Americans, and Japanese) that published more papers on the same patient series. All these factors have led to a possible selection bias. Furthermore, the methods used to evaluate sarcopenia and myosteatosis were not homogeneous (the entire muscle area, or area of the psoas or psoas diameter) as well as the cut-offs used. For these reasons, we propose a multicentric observational prospective study aimed at analyzing the impact of sarcopenia, sarcopenic obesity and myosteatosis in cirrhotic patients not listed for liver transplantation. Primary endpoint: - Evaluation of the impact of sarcopenia on the mortality of cirrhotic patients not on the waiting list for liver transplantation. Secondary end-point: Evaluation of the impact of sarcopenic obesity and myosteatosis on the mortality of cirrhotic patients not on the waiting list for liver transplantation. Evaluation of the impact of sarcopenia/sarcopenic obesity and myosteatosis on the development of complications (hepatic encephalopathy, bacterial infections, ascites, GI bleeding) in cirrhotic patients not on the waiting list for liver transplantation. Evaluation of the impact of sarcopenia/sarcopenic obesity and myosteatosis on the number of admissions and the days of hospitalization for such complications. Evaluation of the subcutaneous fat impact on mortality and morbidity of cirrhotic patients not on the waiting list for liver transplantation. Concordance analysis of the various methods used (different cut-off/area psoas vs. area of all muscles) for the diagnosis of sarcopenia through the analysis of CT scan.

Start: July 2019

The Utility of Breath Biopsy as a Screening Tool for HCC

The aim of this pilot study is to examine whether there is a discriminating ability of the breath sample analysis to capture biomarkers specific to the HCC in the breath of affected individuals. If positive, our research could open up a new horizon for cost-effective and feasible screening tools.

Start: April 2020

Liver Disease in Pregnancy

Liver Diseases in pregnancy represents rare disorders and current data is derived primarily from single centres and retrospective cohorts. Moreover, the population prevalence of these diseases is low and to-date, it has proven difficult to generate reliable data at a patient level. This is a multi-center, prospective cohort study that will open at 3 centers within the UK; and 4 centers in the European Union. The investigators will aim to collect data and blood samples at various time points, for patients presenting with liver disease during pregnancy. The main rationale behind this study is to establish a platform that enables detailed review of the outcomes of these rare diseases; to help classify and stratify patients according to risk and develop interventional studies and care pathways to improve overall outcome.

Start: May 2019

Continuous Passive Paracentesis for Intra-abdominal Hypertension

Liver cirrhosis patients in Intensive Care present intra-abdominal hypertension and this is an independent risk factor for increased organ disfunction and mortality. Patients will be randomized into intermittent or continuous passive paracentesis and the clinical results of these two strategies for preventing and treating intra-abdominal hypertension will compared.

Start: November 2019

Risk Assessment After Acute Upper Gastrointestinal Haemorrhage in Cirrhosis

In previous studies, the investigators used retrospective analysis of cases of acute upper gastrointestinal bleeding in patients with liver cirrhosis from the Fifth Medical Center of the General Hospital of Beijing PLA, China from January 2018 to May 2019. The investigators performed univariate and multivariate analyses of rebleeding risk and death risk based on all data. Then, based on the analysis of 85% of the sampled data, the investigators randomly selected 85% of the patient data to build a model, and then used the remaining 15% of the patient data for model validation. Re-bleeding risk scores and death risk scores were established, respectively. This study intends to prospectively verify the two risk scoring systems described above. After statistical calculations, about 500 patients with liver cirrhosis who plan to undergo emergency gastroscopy for acute upper gastrointestinal bleeding within the next 5 months at the Fifth Medical Center of Beijing General Hospital of China performed in adult patients. The investigators will exclude patients with incomplete or lost follow-up records. Perform patient self-control,using the existing upper gastrointestinal bleeding risk scores (AIMS65, Rockall, and Blatchford) and the previous scoring system model separately, compared with the actual rebleeding rate and mortality for comparison. To verify and revise the rebleeding risk score and death risk score that the investigators constructed earlier.The data were statistical processed by a professional statistician. The establishment of an acute upper gastrointestinal bleeding rebleeding and death risk scoring system for patients with liver cirrhosis can help distinguish patients with high or low risk of rebleeding or death to determine the patient's treatment needs.

Start: January 2020

Albumin for Management of Hypervolemic Hyponatremia (AlbuCAT)

resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period

Start: July 2020

Ivabradine in Cirrhotic Cardiomyopathy

A total of 130 patients with liver cirrhosis who fulfill the criteria of the study, and who have been found to have left ventricular diastolic dysfunction on a screening 2D echocardiography, will then be randomized by Block randomization technique, to two arms in a ratio 1:1(Group A) will receive carvedilol+ Ivabradine targeted therapy for heart rate reduction while Group B will receive Carvedilol alone; and the dosage of drug in the treatment arm will be titrated every week to achieve target heart rate of 50-60/ minute. Patients in the treatment arms, who are unable to tolerate carvedilol due to hypotension episodes, will be offered ivabradine alone to allow achievement of targeted heart rate reduction. All patients will be evaluated at 0,6, and 12 months. The end points will be clinical events, cardiac function improvement, renal function, and mortality.

Start: February 2020

Heparin Like Effect in Acute Variceal Bleeding

This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients. Thromboelastography (TEG) /Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.

Start: November 2019

Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients

A common complication of the progression of cirrhosis is fluid retention (ascites, edema, or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in cirrhotic patients; however, many of these patients demonstrate diuretic resistance, requiring higher doses of the diuretics to achieve adequate diuresis. The cause of this diuretic resistance is hypothesized to be secondary to hypoalbuminemia which has led some providers to give human albumin in combination with loop diuretics to increase intravascular volume and facilitate diuresis. However, this practice remains controversial because minimal data exists to support its efficacy. The purpose of this study is to compare the efficacy of diuretics alone versus diuretics in combination with albumin in cirrhotic patients presenting with fluid retention.

Start: December 2019

Novel Molecular Spectrometric Biomarkers in Blood Plasma as an Early Diagnostic Tool in HCC

Due to providing valuable clinical information while being minimally invasive, blood-based testing will most likely be a prerequisite for future large-scale screening of high-risk populations. As a variety of pathological processes, including carcinogenesis, may cause changes in both the concentration and the structure and spatial arrangement of body biomolecules, the spectroscopic analysis of blood-based derivatives appears to be an appropriate tool for the early detection thereof. The differences observed in the spectral response of healthy individuals and patients may also be specific to a particular type/stage of the disease and, thus, may serve as a reliable diagnostic marker. In order to find sufficiently specific and sensitive biomarkers of early stages of degenerative and cancerous diseases, the co-applicant group at the Department of Analytical Chemistry, University of Chemistry and Technology Prague (UCT Prague), developed a unique approach for the spectroscopic analysis of blood plasma. Using the highly specialized, structure-sensitive methods of chiroptical spectroscopy (electronic circular dichroism - ECD, Raman optical activity - ROA) combined with conventional infrared (IR) and Raman spectroscopy, the first pilot studies yielded promising results with respect to the identification of spectral markers for pancreatic cancer, colon cancer and type 1 diabetes mellitus. In addition, metabolomics appears to be a very progressive approach to finding potentially suitable molecules to distinguish between healthy and cancer-affected individuals. Therefore, the investigators believes that this multimodal approach will allow for the identification of hepatocellular carcinoma (HCC). In our research, the focus will be on the identification of novel biomarkers in blood plasma that would exhibit sufficient sensitivity and specificity to detect early and potentially curable HCC stages, and that would be potentially useful for routine screening of this disease in well-defined at-risk groups.

Start: October 2017

Microbiome Translocation in Different Circulatory Compartments in Decompensated Cirrhosis

Acquired dysfunctional immunity in cirrhosis predisposes patients to frequent bacterial infections contributing to disease progression and may lead to the development of acute-on-chronic liver failure (ACLF). Spontaneous bacterial peritonitis (SBP) is one of the most frequent infections in cirrhosis and therefore a trigger for ACLF. ACLF is characterized by systemic inflammation even in the absence of confirmed infection and associated with poor outcome. The source of ascites infection, especially in case of culture-positive SBP and bacterascites, is suspected to be bacterial translocation from gut. In decompensated cirrhosis, data on the gut microbial translocation in different circulatory compartments is limited. Moreover, the link between gut microbiome and systemic inflammation in liver disease has still not established. The transjugular intrahepatic portosystemic shunt (TIPS) is applied to treat portal hypertension which frequently leads to intestinal bleeding, life-threatening esophageal bleeding and ascites. Under the procedure of TIPS, the vein blood samples in different compartments (superior mesenteric vein, portal vein and hepatic vein) from patients with decompensated liver cirrhosis are available. Metagenomic next-generation sequencing (mNGS) is a promise approach for the diagnosis of infectious disease because a comprehensive spectrum of potential causes (viral, bacterial, fungal, and parasitic) can be identified by a single assay. Previous study reported that mNGS of cerebrospinal fluid can be applied to diagnosis of meningitis and encephalitis. Comparing to traditional bacterial culture method, mNGS method is more sensitive and rapidly in pathogen detection. Therefore, the circulating microbiome in different compartment can be characterized by means of mNGS. Here, the study aim to investigate the circulating microbiome from superior mesenteric vein (first venous outflow in gut-liver axis), hepatic vein (liver outflow), peripheral vein and ascites from patients with decompensated liver cirrhosis receiving TIPS. Before TIPS, fecal sample and unary sample are collected. And mNGS method is performed to identify the pathogen in ascites,fecal and blood samples in a single center. Ultimately, the study aim to build up the link between gut microbiome translocation and liver disease.

Start: November 2019

Bleeding in Hospitalized Patients With Liver Disease Undergoing Invasive Procedures

Patients with cirrhosis are frequently hospitalized and often undergo procedures. Knowledge surrounding bleeding risk is sparse and practice patterns vary across centers in regards to bleeding prophylaxis. The goal of this study to is to obtain more knowledge regarding risk factors for procedural related bleeding in patients with cirrhosis and to develop a predictive model to risk stratify patients before undergoing procedures. Through collaboration from centers across the world this study should provide information on prevalence of bleeding and variation in practice patterns for prophylaxis.

Start: November 2019

Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy

Individuals with cirrhosis are likely to develop overt hepatic encephalopathy for which diagnostic modalities and treatment options are limited. The purpose of this study is to determine if individuals with cirrhosis who experience hepatic encephalopathy would benefit from investigational microbiota restoration therapy due to their inherent cognitive alterations. Analysis for a correlation between changes in microbiome composition and specific blood biomarkers could allow for earlier diagnosis of HE which could then be treated earlier and with novel treatments.

Start: December 2019

A Study of MHE in Patients With Liver Diseases

The investigators analyze the diagnostic efficacy of blood ammonia, neurophysiological/psychological tests and blood markers on MHE; to see the progression of HE under the condition of the drugs intervention and no drugs intervention in clinical real world.

Start: May 2019

Plasma Exchange in Acute on Chronic Liver Failure

Acute on chronic liver failure (ACLF) is a distinct syndrome in patients with chronic liver disease with rapid clinical deterioration and has high short term mortality within one month.Despite aggressive clinical care, only half of the patients could survive an episode of ACLF. The investigators hypothesized that the early treatment with therapeutic plasma exchange with plasma and albumin in ACLF patients might improve overall survival in carefully selected patients by removing cytokines, chemokines and toxic substances.

Start: August 2019