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Liver Failure clinical trials

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NCT ID: NCT02584283 Completed - Liver Failure Clinical Trials

Dual Hypothermic Oxygenated Perfusion of DCD Liver Grafts in Preventing Biliary Complications After Transplantation

DHOPE-DCD
Start date: January 2016
Phase: Phase 3
Study type: Interventional

Rationale: Recent publications report good results of controlled donation after circulatory death (DCD) Maastricht category III liver transplantation when strict donor-recipient matching is applied and ischemia times are kept to a minimum. However a major concern remains the high rate of biliary complications after transplantation of DCD livers. Non-anastomotic biliary strictures (NAS) occur in 29% of patients receiving a DCD graft whereas the incidence of NAS in recipients of donation after brain death (DBD) liver grafts is 11%. NAS are associated with higher morbidity and increased cost of liver transplantation. Injury to the biliary epithelium and the peribiliary vascular plexus occurring during donor warm ischemia and static cold storage (SCS) has been identified as a major risk factor for development of NAS. Machine perfusion has been proposed as an alternative strategy for organ preservation, offering the opportunity to improve the quality of the organ by providing oxygen to the graft. Experimental studies have shown that end-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) helps liver grafts to recover from ischemia by restoring mitochondrial function. Moreover, DHOPE has been shown to provide better preservation of peribiliary vascular plexus of the bile ducts, which could be an important step forward in reducing the incidence of NAS after transplantation. Objective: To study the efficacy of end-ischemic DHOPE in reducing the incidence of NAS within six months after controlled DCD (Maastricht category III) liver transplantation. Study design: An international, multicenter, prospective, randomized, controlled, interventional, clinical trial with a two parallel arm approach (treatment/control). Study population: Adult patients (≥18 yrs old) undergoing a liver transplantation with a liver graft procured from a controlled DCD donor (Maastricht category III) with a body weight ≥40 kg. Intervention: In the intervention group liver grafts will be subjected to two hours of hypothermic, oxygenated perfusion at the end of SCS and before implantation. In the control group donor liver grafts will be preserved in accordance to standard practice by SCS only. Main study parameters/endpoints: The incidence and severity of symptomatic NAS as diagnosed by an Adjudication committee (who are blinded for the group assignment) by means of magnetic resonance cholangiopancreatography (MRCP).

NCT ID: NCT02583698 Completed - Clinical trials for Acute on Chronic Liver Failure

Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.

NCT ID: NCT02573727 Completed - Clinical trials for Acute on Chronic Liver Failure

To Compare the Response Rate of Noradrenaline vs. Terlipressin in Hepatorenal Syndrome in Patients With Acute on Chronic Liver Failure

Start date: October 2015
Phase: N/A
Study type: Interventional

Continous infusion of nor adrenaline + albumin Continous infusion of terlipressin + albumin Response will assessed at every 48 hour (i) Complete response: Regression of acute kidney injury stage with reduction of S. Cr within 0.3 mg/dl of baseline (ii) Partial response: Regression of acute kidney injury stage with reduction of S. Cr to ≥0.3 mg/dl above baseline (iii) No response: No regression of acute kidney injury Treatment will be extended until reversal of HRS (decrease in creatinine below 1.5 mg/dL) or for a maximum of 7 days after rescue treatment will be followed. If intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.

NCT ID: NCT02557724 Completed - Liver Failure Clinical Trials

Mobilization of Mesenchymal Stem Cells During Liver Transplantation

Start date: September 2015
Phase:
Study type: Observational

To study if the administration of corticoid hinder or enhance the mobilization of Mesenchymal Stem Cells (MSCs) in the peripheral blood during liver transplantation and whether this affects the outcome with respect to graft versus host response.

NCT ID: NCT02544113 Completed - Liver Failure Clinical Trials

A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation

Start date: December 2015
Phase: Phase 2
Study type: Interventional

This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult patients receiving a single organ liver transplant from a deceased donor; the purpose being to determine the efficacy of Thymoglobulin® induction and delayed initiation of CNI in the long-term preservation of renal function after liver transplantation. This study is based on the outcomes of an earlier phase 1 pilot study which was performed at the Cleveland Clinic. This study will be conducted at 3 centers, with 110 subjects randomized 1:1 into two groups: Group 1 will receive Thymoglobulin® induction, (4.5 mg/Kg, in 3 doses of 1.5 mg/Kg/dose) with delayed initiation of CNI to begin on Day 10 post LT. Group 2 will receive early CNI initiation (to be started no later than Day 2 post LT), and no Thymoglobulin® induction (or any other antibody). All subjects will also receive a maintenance immunosuppressive regimen consisting of corticosteroids and mycophenolate mofetil (MMF) according to standard of practice in orthotopic liver transplantation (OLT). Subjects will be consented pre-transplant. Participation may last up to 12 months post OLT. There are 15 study-related visits which will be completed during standard of care (SOC) visits.

NCT ID: NCT02467348 Completed - Clinical trials for Acute on Chronic Liver Failure

Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.

Start date: March 15, 2015
Phase: N/A
Study type: Interventional

All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on chronic Liver Failure). ACLF will be randomize into Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8 gms/L of ascitic fluid Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin

NCT ID: NCT02460510 Completed - Acute Liver Failure Clinical Trials

Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF

Start date: June 2014
Phase: N/A
Study type: Interventional

Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations. Patients would also be screened for the assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of 144-155 mmol/L .Both the groups would receive other supportive measures such as head end elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard medical treatment.

NCT ID: NCT02457637 Completed - Clinical trials for Liver Failure, Acute on Chronic

Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study

Ch-CANONIC
Start date: January 1, 2015
Phase:
Study type: Observational

Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute deterioration of liver function, culminating in multiple organs failure and high short-term mortality. Currently, there are differences in definitions and descriptions between western and eastern types of ACLF, especially in the definition of chronic liver disease and its precipitating events. The CANONIC (EASL-CLIF ACLF in Cirrhosis) study put forward CLIF-SOFA (chronic liver failure-sequential organ failure assessment) scores as the clinical diagnostic criteria of ACLF in 2013. Although the Asian Pacific Association for the Study of the Liver (APASL) reached a consensus for diagnostic criteria of ACLF in 2008, it is based on expert opinion. This prospective multicenter clinical trial is launched to clarify the eastern type of ACLF (HBV related) and estimate whether the eastern and western (alcoholic related) types are homogenous. 3 key points of concern are: (1) Whether HBV and non-HBV ACLFs are belonged to a homogenous disease entity which share the same diagnostic criteria, disease grades classification and prognostic model? (2) Whether acute deteriorating patients from cirrhosis or from mild fibrosis (S1-S2) belong to a homogenous entity? (3) To clarify if there are heterogenous groups in APASL criteria diagnosed ACLF patients. 14 Chinese national wide liver centers have been included. Continuous hospitalized chronic liver disease patients of various etiologies (including both cirrhotic and non-cirrhotic) with acute decompensation (AD) or acute hepatic injury (ALI) (aminotransferase > 3NL(normal level)) will be recruited from January to December 2015. Biochemical parameters, organ failure will be collected and evaluated at day 1,4,7,14,21 and 28 after enrollment. Patients'death and LT (liver transplantation) are the primary and secondary endpoints of observation. Mortality and LT rate will be calculated at 28 days,90 days,180 days,1 year and 2 years after enrollment. Considering there will lack of liver biopsy in most of the patients, both CT and FibroScan as supplementary methods to differentiate non-cirrhotic patients. The patients will be continuously followed up once a month until the 24th month after hospital discharging and follow similar hospitalization process again whenever they have new ALI or AD. Data about the patients from stable chronic liver disease to deterioration will be acquired analyzed according to the questions hoped to resolve.

NCT ID: NCT02455115 Completed - Acute Kidney Injury Clinical Trials

Renal Perfusion, Filtration and Oxygenation After Liver Transplantation -Effects of av Postoperative Blood Pressure

Start date: January 2015
Phase: N/A
Study type: Interventional

Comparing the effects of MAP 60, 75 and 90 mmHg, respectively, on renal blood flow, glomerular filtration rate and renal oxygen demand in patients with terminal liver failure directly after liver transplantation.

NCT ID: NCT02387814 Completed - Clinical trials for Hepatic Insufficiency

A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated. This study will last approximately 3 weeks for each participant, including check-in and follow-up.