Hepatorenal Syndrome

Researchers are studying the metabolism of cells in the ascites fluid of ovarian cancer patients to better understand the tumour environment. This observational study involves women aged 18 and older who have ascites caused by diagnosed ovarian cancer. The study aims to trace how glucose is taken up and metabolized by tumour and T cells in the ascites. Participants will receive an intravenous infusion of specially labeled glucose ([U-13C]glucose) during their scheduled paracentesis procedure. The infusion starts with 8 grams of labeled glucose in 60 mL over 10 minutes, followed by 4 grams in 30 mL over one hour, continuing until the ascites fluid is drained or up to 5 hours. A continuous glucose monitor tracks blood glucose levels throughout. Samples of ascites fluid collected during the infusion will be kept on ice and analyzed for metabolic activity and metabolite profiles using flow cytometry and mass spectrometry. During the study, participants will wear a glucose monitor before paracentesis and have ascites fluid collected hourly for up to 5 hours. Researchers will measure glucose enrichment and compare metabolic pathways in different cell types within the ascites. They will also correlate metabolic profiles with T cell function. The study involves close monitoring of blood glucose and sample analysis to understand tumour and immune cell metabolism in ovarian cancer ascites.

Researchers are investigating new non-invasive methods to predict hepatic venous pressure gradient (HVPG), a key measure in managing portal hypertension in cirrhosis. This study compares three-dimensional magnetic resonance elastography (3D-MRE) with two-dimensional magnetic resonance elastography (2D-MRE) to develop a risk stratification system that can guide personalized treatment for portal hypertension. Cirrhosis and portal hypertension pose significant health challenges, making less invasive diagnostic tools important for patient care. Participants will undergo imaging using either 3D-MRE or 2D-MRE, both performed on a 3.0-T MRI system with an eight-channel body coil. The study features two groups: one developing a model using 3D-MRE and a control group using 2D-MRE. Hepatic venous pressure gradient measurements are taken by trained radiologists following standard procedures. Comparing these imaging techniques aims to evaluate their accuracy in assessing portal hypertension. During the study, participants will have imaging and HVPG measurements within one month to ensure data consistency. Researchers will assess the accuracy of 3D-MRE and 2D-MRE features for predicting portal hypertension over a 12-month period. The study monitors participants through these diagnostic tests and evaluates how well the imaging models can predict HVPG, contributing to safer, more convenient management of cirrhosis-related complications.

Hepatorenal syndrome (HRS) is a condition causing acute kidney injury in patients with liver disease, often due to circulatory changes from vasodilators like nitric oxide. It presents with elevated serum creatinine, benign urine sediment, and low urine sodium. The study evaluates outcomes in patients with HRS by comparing various treatment methods to better understand their effects and support treatment decisions. The research is a retrospective analysis of patients with HRS, focusing on treatments including vasoconstrictors, albumin, continuous renal replacement therapy (CRRT), Molecular Adsorbent Recirculating System (MARS), and transjugular intrahepatic portosystemic shunts (TIPS). CRRT is considered especially for patients with severe electrolyte imbalances and can serve as a bridge to liver transplantation, although it carries risks such as low blood pressure and cardiac events. TIPS may improve kidney function by reducing portal pressure. Participants are patients over 18 hospitalized between April 2019 and April 2023 diagnosed with HRS. Researchers will review medical records to assess treatment outcomes, focusing on primary outcomes for HRS-AKI patients over four years and post-transplant mortality rates. The study involves no interventions or additional procedures beyond data analysis. The total participation involves reviewing historical data, with no direct patient involvement or follow-up.

Researchers are evaluating the safety of siplizumab, an investigational anti-CD2 monoclonal antibody, as an induction immunosuppressive treatment in adult patients with autoimmune liver diseases (AILD) such as autoimmune hepatitis (AIH) and primary sclerosing cholangitis (PSC) undergoing liver transplantation. This pilot, open-label phase 1 study addresses the need for effective therapies to prevent immune-mediated graft injury and complications post-transplant. Siplizumab targets memory T cells involved in rejection and autoimmunity after liver transplantation in these patients. Participants will receive two intravenous doses of siplizumab at 0.6 mg/kg: one dose intraoperatively on the day of transplant (Day 0) and another on Day 4 post-transplant. Up to eight subjects will be enrolled. The study lasts about 15 months, including approximately three months waiting for transplant and 12 months of follow-up after transplantation. During the study, participants will be monitored for serious infections within the first month after transplant and for other outcomes such as immune-mediated liver injury, graft loss or death, rejection episodes, donor-specific antibodies, and disease recurrence over 12 months post-transplant. Assessments will include safety, tolerability, pharmacokinetics, and pharmacodynamics of siplizumab, with ongoing observation throughout the study period.

Researchers are investigating the relationship between the volume of normal liver tissue removed during surgery, called resected normal liver parenchymal volume (RNLV), and the risk of liver failure after liver surgery (post-hepatetotomy liver failure, or PHLF). This observational study focuses on patients diagnosed with hepatocellular carcinoma (HCC) or intracholangiocarcinoma (ICC) who have undergone liver resection. The goal is to build and assess a personalized predictive model using RNLV to better estimate the risk of PHLF before surgery. The study collects data retrospectively from over a thousand patients treated at the investigator’s center. Patients are grouped based on whether they developed liver failure after surgery, defined by two sets of criteria known as the 50-50 criteria and ISGLS criteria. The research evaluates how well the RNLV-based model predicts PHLF and compares its usefulness to other methods, especially for patients with large or multiple liver tumors. Participants' medical records and surgical details are reviewed to calculate RNLV and assess liver failure outcomes within 30 days after surgery. The main outcome is the predicted probability of PHLF using the newly developed model. This approach aims to improve preoperative risk assessment to support safer liver surgeries. The study is sponsored by the National Natural Science Foundation of China and runs through the end of 2026.

This research aims to explore the relationship between muscle composition, measured by an MRI-based Muscle Assessment Score (MAsS), and negative outcomes in people being evaluated for liver transplant. Sarcopenia, or loss of muscle volume and function, is common in end-stage liver disease and is linked to worse health outcomes and higher risk of death. The study also seeks to understand how muscle health interacts with donor liver characteristics to affect transplant success and survival. Participants will undergo MRI scans during their liver transplant evaluation, where the MAsS will be added to the standard MRI to assess muscle volume and fat infiltration. This score combines measures of muscle size and fat content to provide a detailed picture of muscle health. The study will use these MRI assessments to identify patients at high risk of adverse outcomes, both before and after transplant, over a one-year period. During the study, participants' muscle health and transplant outcomes will be monitored through MRI and clinical follow-up for one year. Researchers will evaluate changes in the MAsS while waiting for transplant and record adverse events and mortality. This approach aims to provide a standardized, objective measurement to better predict risks in liver transplant candidates and improve understanding of factors impacting transplant success.

Chronic liver diseases affect over 800 million people worldwide and cause about 2 million deaths each year. Early diagnosis and prediction of disease progression remain major challenges, as current blood markers and panel tests lack sensitivity and specificity. This research focuses on albumin post-translational modifications (PTM) as potential early biomarkers that may indicate future liver damage and help predict disease progression in patients with chronic liver disease. The study will recruit 756 patients with compensated fibrosis from six university hospitals and follow them for up to three years. Blood samples will be taken at the start and during follow-up visits at one, two, and three years, either through additional tubes added to routine samples or using leftover samples. These will be analyzed centrally to assess albumin isoform profiles and ligand-binding capacities using the Serum Enhanced Binding (SEB) test. Participants will have no extra visits beyond their usual care appointments. Data including blood results and medical records will be collected at each visit. Researchers will evaluate the ability of albumin modifications and the SEB test to predict liver disease progression, monitor changes over time, and confirm characteristic albumin patterns related to liver injury. The study aims to improve liver disease diagnostics and patient care by validating these novel biomarkers.

Researchers are evaluating the safety, tolerability, and effectiveness of transplanting hepatocytes into lymph nodes for people with end-stage liver disease (ESLD). This Phase 2a open-label dose escalation study aims to find the right dose and assess how well the transplanted cells engraft in subjects with ESLD caused by various liver conditions. The study includes up to 12 participants and is sponsored by LyGenesis, Inc. Participants receive allogenic hepatocytes suspended in a preservation solution, which are transplanted into periduodenal lymph nodes using endoscopic ultrasound. The study uses a dose-escalation approach, gradually increasing the number of lymph nodes treated. Subjects also receive immune-suppressing medications including tacrolimus capsules and a short course of prednisone to support the transplant. During the study, participants are monitored closely for safety and how well the hepatocytes engraft at 12 weeks, along with liver function tests assessed up to 52 weeks. Researchers evaluate dosage selection, safety, and efficacy at week 12, and the treatment's effect on liver function over one year. Participants must comply with study requirements and avoid alcohol during the trial, which lasts over a year including follow-up visits and assessments.

Researchers are evaluating patients with chronic liver diseases linked to hepatic steatosis, a condition where fat accumulation in the liver may cause inflammation and scarring. This condition can lead to serious liver problems such as cirrhosis, liver failure, and death. The study aims to better understand the underlying mechanisms of these diseases and to identify specific diagnostic markers and potential future treatments by examining tissue-level characteristics. This observational study involves collecting detailed biological samples and data from adults with various chronic liver diseases, including autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis, alpha-1-antitrypsin deficiency, and others. The study does not involve any drug or device interventions but focuses on in-depth phenotyping and metabolic assessments at multiple time points. Participants will be observed and evaluated over a period of up to 10 years. Researchers will collect plasma samples at several intervals and aim to identify diagnostic classifiers to distinguish between different chronic liver diseases. The study includes regular assessments and long-term monitoring to gather comprehensive data on metabolic disturbances and disease characteristics. Participation involves informed consent and adherence to scheduled evaluations without treatment administration.

Researchers are evaluating the safety and effectiveness of apixaban combined with carvedilol compared to carvedilol alone in preventing complications related to portal hypertension in patients with cirrhosis. This is a prospective, randomized, single-blind, placebo-controlled study conducted at the Asian Institute of Medical Sciences Hospital in Hyderabad, Pakistan. The goal is to provide local evidence for using apixaban in managing cirrhosis and its complications, such as variceal bleeding and portal vein thrombosis. Participants are randomly assigned to one of two groups: one receives apixaban 2.5 mg twice daily plus carvedilol, while the other receives a placebo plus carvedilol. Carvedilol doses start at 6.25 mg once daily and are gradually increased every 2 to 4 weeks to a target of 12.5 mg twice daily, based on heart rate and blood pressure. Those with high-risk varices undergo endoscopic band ligation before randomization for safety. The treatment and follow-up last for 12 months. During the study, participants have visits at baseline, 2 weeks, and at 1, 3, 6, 9, and 12 months. Assessments include vital signs, blood tests, abdominal ultrasound with Doppler, and transient elastography. Adherence is tracked through pill counts and diaries. Researchers will monitor the first occurrence of portal hypertension complications, bleeding events, hospitalizations, and mortality. Safety is carefully reviewed by an independent board throughout the trial.