View clinical trials related to End Stage Liver Disease.
Filter by:Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care
In this project, we plan to evaluate whether a new, rotational thromboelastometry-guided algorithm (ROTEM) to guide hemostatic resuscitation decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured. We plan to enroll 140 patients having ACLF with variceal bleeding randomized into two groups: one will be treated conventionally using clinical judgement and standard coagulation tests such as prothrombin time, platelet count, etc. the other treated using a ROTEM-based algorithm. They will be followed for development of rebleeding, complications of transfusion and any signs of infection after hospitalization
The project is essential to understand the impact of the COVID-19 pandemic in patients with Chronic Liver Disease (CLD). The impact has been felt due to direct risk of COVID infection in self, or in caregivers, lack of access to services during lockdown, interruptions in transplant listing and waitlist mortality. Briefly, the following points will be focused during the study. 1. Long haul COVID-19 related symptoms. 2. Impact on health and delay in interventions or drug therapy due to interruption of physical outpatient services. 3. Impact on emergency admissions due to refractory ascites, new decompensation, variceal bleeding etc 4. Impact on delayed transplant listing and waitlist mortality 5. Impact on post-transplant patients with lack of access to drug monitoring/ physical OPD 6. Impact on delay in interventions due to hepatobiliary malignancy. 7. Effects of COVID-19 infection, vaccination (single dose, two doses) and no vaccination and protective antibody levels in patients with chronic liver disease and post-transplant recipients. 8. Determination of dose protocol and need for booster vaccination in patients with CLD and post liver transplant recipients.
In critically ill patients with liver disease like cirrhosis or ACLF, fluid therapy needs to be instituted after identification of patients who will be fluid responsive and initiate appropriate inotropes early to prevent the mortality associated with fluid overload. The parameters and methodology used for assessing fluid responsiveness have been studied earlier, but the optimum method is not established. Existing recommendations based on data regarding fluid responsiveness and choice of fluid for resuscitation from intensive care units in general cannot be applied to those with liver disease as the hemodynamic alterations that occur with liver disease, presence of hypoalbuminemia at baseline and presence of cardiac dysfunction interfere with the conventional methods of fluid status assessment, fluid responsiveness as well as the response to different types of resuscitation fluids. Therefore the investigators attempt to compare various methods to estimate current intravascular volume status of patient which could be helpful in guiding fluid therapy.
Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections. Liver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored. Recent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients. Investigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.
The CYTOHEP study is a prospective, randomized, single center, open-label, controlled intervention trial to assess the benefit of extracorporeal hemoadsorption using the CytoSorb device in patients with acute-on-chronic liver failure. The primary goal for this trial is to assess whether the CytoSorb device used in addition to continuous renal replacement therapy (CRRT) will be able to significantly reduce bilirubin in the patient blood as compared to the control group treated with CRRT alone (i.e., without extracorporeal hemoadsorption). The rationale for this study is based on considerations about the role of systemic inflammation in acute decompensation of liver cirrhosis and ACLF, in-vitro data of the effectiveness CytoSorb for the removal of molecules with a pathophysiological role in acute-on-chronic liver failure, and recent reports on the successful use of extracorporeal hemoadsorption in combination with CRRT in critically ill patients with acute liver dysfunction.
This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups. 1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis 2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets 3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.
End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia.
In the past ten years, the extracorporeal liver support system has been widely used in clinical practice as a first-line treatment of liver failure. Plasma exchange (PE) can remove toxic substances in ACLF patients, reduce liver damage, and replenish coagulation factors, albumin and immunoglobulins, thereby improving the liver's microenvironment and accelerating liver regeneration and functional recovery. The ACLF study showed that PE can improve the symptoms of patients and improve the short-term prognosis of patients, but there are still studies showing that PE does not significantly improve the short-term prognosis of patients. Therefore, the therapeutic effect of PE on ACLF is still controversial. We consider that some people may benefit from plasma exchange, and new indicators are needed to guide disease stratification treatment. Our multi-center prospective data show that plasma exchange has a tendency to improve survival in ACLF-2. After stratifying with ADP inhibition rate in ACLF-2, patients with ADP inhibition rate greater than 30% will be treated 28 days after PE treatment. The prognosis is improving. Therefore, we consider that PE is expected to reduce the mortality of patients with ACLF 2 with an ADP suppression rate greater than 30%, but prospective large-sample clinical studies are still needed.
Study groups: The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors). Once a DCD or a DBD with extended criteria (ECD-DBD) meets the inclusion criteria, they are randomized as follow: 1. 20 liver grafts from DCD after normothermic regional perfusion (NRP) matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted. 2. 40 liver grafts from ECD-DBD matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted