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End Stage Liver Disease clinical trials

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NCT ID: NCT04621812 Recruiting - Liver Cirrhosis Clinical Trials

Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.

Start date: November 8, 2020
Phase:
Study type: Observational

Efficient immunosuppressive therapy and improved surgical techniques have developed liver transplantation as a well-established and life-saving treatment. The 1-year survival rate of approximately 85-90%. Acute cellular rejection (ACR) is one of the main causes of liver dysfunction (LD) after liver trans- plantation, occurring 30% to 70% of transplanted patients and potentially leading to allograft failure. In addition to ACR, presence of sepsis, drug injury, viral infections like CMV or recurrence of viral hepatitis is also other causes of graft dysfunction. Laboratory tests are commonly used as less invasive methods of monitoring allograft rejection, but they are not specific to rejection and are often elevated in other types of graft dysfunction too. Till date the immunosuppressive regimen in liver transplant recipient is considered as an art in absence of an objective measures of the immune state. Therapeutic drug monitoring has little value in the assessment of the immune state and is always used as a supportive guide. The development of specific immune monitoring assays to measure the net immunosuppressive state in a transplant recipient would allow a more individualized therapeutic regimen Patients with altered gut microbiota had more chances of infection and longer course of hospital stay. Probiotics could mediate beneficial effects in graft rejection. Dysbiosis activates T cells through PAMPS and causes the inflammatory injury in the graft liver. The studies shown that lower Eubacteria, Bifidobacterium, Faecal bacterium and Lactobacillus with abundance of Enterococcus and Enterobacteriaceae. They restored to near normal after transplant in majority. This is known that there is a dysbiosis in the natural history of ACLF or decompensated cirrhosis, and often correlated to complications like-endotoxemia, sepsis, worsening liver failure and poor survival. This has led to consider fecal microbiota modulation as an emerging therapy. Liver transplant and consequent recovery, there is over all change in the recipient homeostatic milieu as well as the immune milieu and the same may be happening to the gut flora too.It's well known that liver has animprint of resident gut flora. The preliminary rat model showed alteration of gut flora to predict the development acute cellular rejection before it happens. Similarly the risk of infection is more among transplant recipients with decreased microbial diversity after liver transplant. However the data is scanty and there is an urgent need to understand the mechanism.. The present study was necessitated in view of emerging role of gut microflora and its influence on immune remodeling for the prediction of infection, rejection and may be an early biomarker for the graft dysfunction. This may be of varied cause in liver transplant recipients along with its impact on overall immune status. Uniqueness of the present study will be to understand the mechanism of development of sepsis or graft dysfunction in due course of time using high-throughput tools of single cell analysis in whole blood and gut microbiota alterations among liver transplant recipient as a cause for graft dysfunction in first year of live donor liver transplant.

NCT ID: NCT04613921 Recruiting - Liver Cirrhosis Clinical Trials

Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs

CHANCE
Start date: July 8, 2021
Phase:
Study type: Observational

Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

NCT ID: NCT04597164 Recruiting - Clinical trials for Hepatitis B, Chronic

Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF

Start date: December 22, 2020
Phase:
Study type: Observational

This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.

NCT ID: NCT04585672 Recruiting - Clinical trials for Liver Failure, Chronic

Ammonia Metabolism Assessed by Ammonia Infusion

NH4 inf
Start date: August 19, 2020
Phase: N/A
Study type: Interventional

The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis.

NCT ID: NCT04578301 Recruiting - Surgery Clinical Trials

Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease

PERSEVERE
Start date: September 22, 2020
Phase:
Study type: Observational

Prospective, observational study to define precipitants and predictors of development of Acute-on-Chronic Liver Failure (ACLF) after surgical interventions, allowing to develop a risk stratification for elective procedures in cirrhotic patients. As well as identifying molecular mechanisms of post-interventional ACLF and thus preparing the ground for development of new therapeutic approaches.

NCT ID: NCT04564651 Recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Platelet Transfusion in Acute-on Chronic Liver Failure

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Acute on-chronic liver failure (ACLF) is a severe liver disease with a 28-day mortality rate of up to 40%. When the patients get 3 or more organ failures, the 28-day mortality rate is up to 82.6%. Though the ACLF patients have high short-term mortality, and the only effective treatment method is liver transplantation. However, few patients can be treated due to the scarcity of liver source, rapid disease progression and short transplantation window. Our team evaluated the platelet function of 100 patients with ACLF by using the thromboelastograghy (TEG 5000). It was found for the first time that the reactivity of platelets of ACLF patients decreased, and the platelet inhibition rate (especially the ADP pathway) was related to patients'short-term prognosis. When the ADP inhibition rate was 70%, the patients'28-day mortality was up to 100%. However, the mechanism of low platelet response to ADP in ACLF patients is still unclear. We found that the platelet function in patients with ACLF 2-3 grade and inhibition rate beyond 70% was improved and the 28-day mortality decreased after platelet transfusion. Whether platelet transfusion can prolong survival time needs to be determined in a prospective controlled study. Therefore, this study is expected to find a new therapeutic method to reduce the mortality of patients with ACLF.

NCT ID: NCT04525625 Recruiting - Acute Kidney Injury Clinical Trials

Risk Factors for Acute Kidney Injury in Critically Ill Patients With Acute-on-Chronic Liver Failure

Start date: February 1, 2021
Phase:
Study type: Observational

Acute kidney injury (AKI) is one of the most important factors associated with increased mortality in patients with acute-on-chronic liver failure (AoCLF). Early identification and treatment of this subgroup of patients may improve survival and decrease ICU length of stay. As kidney ischemia is one of the main mechanisms responsible for AKI in AoCLF, an increase in urinary to arterial partial pressure of oxygen may help in the early diagnosis of renal failure. For this arterial and urinary oxygen pressure will be measured at ICU admission, on day 1 and day 3 of ICU stay. Diagnosis of AKI within the first 28 days after ICU admission will be recorded

NCT ID: NCT04496479 Recruiting - Clinical trials for End Stage Liver Disease

Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes

Start date: March 11, 2022
Phase: Phase 2
Study type: Interventional

This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.

NCT ID: NCT04431375 Recruiting - Hepatitis B Clinical Trials

Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV

Start date: June 22, 2020
Phase: N/A
Study type: Interventional

A randomized controlled trial to study the efficacy of addition of FMT & plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure. In this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples & stool samples will be taken & analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE & SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange & FMT adds benefit compared to tenofovir treatment alone .

NCT ID: NCT04335058 Recruiting - Clinical trials for Iron Deficiency Anemia

Lactoferrin in Treatment of Fe Deficient Anemia In Cirrhosis

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Iron deficiency and altered homeostasis due to inflammation and decreased iron utilization are main factors involved in anemia in liver disease. Lactoferrin is a first line defence protein for protection against microbial infections and subsequent development of systemic disease as seen with systemic inflammatory response syndrome (SIRS) and sepsis. Lactoferrin with iron has been shown to be efficacious with anemia in chronic disease, in pregnancy and in cancer patients with fewer side effects than oral iron alone. High exposure to iron is associated with increased inflammation which is associated with worse cardiovascular outcomes. Lactoferrin can help reduce the total iron dose and hepatic inflammation.