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Liver Failure clinical trials

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NCT ID: NCT00805610 Withdrawn - Liver Failure Clinical Trials

Hepatocyte Transplantation in Liver Failure

Start date: June 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators research will examine the safety and efficacy of hepatocyte transplantation in the patient with acute liver failure without history of chronic disease. The investigators will study the effectiveness in providing a bridge of support for patient survival until whole organ transplantation is possible. This support may also be a bridge to recovery; by allowing the native liver to recover so that orthotopic liver transplant is not necessary. The investigators will also study the safety and efficacy of hepatocyte transplantation in the patient with chronic liver disease. Underlying etiologies of chronic disease may arise from cirrhosis, fibrosis or inherited metabolic disorders. The investigators will examine cell transplantation in end-stage patients not eligible for whole organ transplant. These patients may benefit with an amelioration of symptoms that will allow other therapeutic treatments. The investigators study will also examine the ability of transplanted hepatocytes to treat inherited metabolic diseases (ex., Crigler-Najjar Disease, Familial Hypercholesterolemia, Urea Cycle Disorders). Cell transplant may also act as a 'bridge' to whole organ transplant or improve function, permitting easier disease control through traditional therapy.

NCT ID: NCT00772252 Recruiting - Critical Care Clinical Trials

Oxidative Stress and Microcirculation in Patient With Hepatic Failure Undergoing Liver Support Treatment

Start date: August 2008
Phase: N/A
Study type: Observational

Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA. It will damage the cell and result in organ dysfunction. We believe that in patients, who have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating System for bridge therapy will suffer from the injury of reactive oxidative species, too. It will damage the kidney, lung, cerebral cortex, and other organs. It may result in death before the recovery of liver function or undergoing liver transplantation. Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 2. Investigate the microcirculation status and risk factors in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 3. Study the relationship between oxidative stress and microcirculation status. 4. Study the correlation between oxidative stress and prognosis. 5. Study the correlation between microcirculation status and prognosis.

NCT ID: NCT00772148 Completed - Liver Failure Clinical Trials

Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney and liver. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is an investigational drug. This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a liver transplant in patients randomly assigned (by chance, like flipping a coin) to take either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In addition, patients will remain on study drug for 360 days in order to evaluate the relative safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.

NCT ID: NCT00764049 Completed - Cirrhosis Clinical Trials

Single Pass Albumin Dialysis in Patients With Cirrhosis

DACAR
Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

NCT ID: NCT00736541 Completed - Clinical trials for End Stage Liver Failure

N-acetylcysteine in Liver Transplantation

NAC
Start date: July 2004
Phase: N/A
Study type: Interventional

N-acetylcysteine (NAC) is used to treat Tylenol toxicity. NAC is a rich source of the sulfhydryl group (SH) which is important for replenishing the body's glutathione stores. Glutathione acts as a free radical scavenger, to decrease the damage that would be caused by those toxic radicals. Patients who undergo orthotopic liver transplantation (OLT) have a high incidence of post-operative renal dysfunction. The most common etiology of post-operative renal dysfunction is related to high levels of toxic free radicals. Free radicals may contribute to primary liver graft failure or delayed liver graft function. Specific Aims & Objectives: The primary objective of this study is to evaluate the efficacy of NAC in improving liver graft performance and lowering the incidence of post-operative renal dysfunction. The secondary objectives are to investigate the effect of NAC on endogenous glutathione body stores and its effect on FK506 induced toxicity.

NCT ID: NCT00695617 Unknown status - Liver Failure Clinical Trials

Citrate Anticoagulation During MARS Treatment

Start date: July 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The optimal anticoagulation procedure during MARS treatment has not been defined. In various multi-centre trials, such as MARS-RELIEF, anticoagulation procedures are left to the discretion of the treating physician. On the one hand, given the increased risk of bleeding associated with liver failure, high dosage of anticoagulation therapy should be avoided. On the other hand, contact of blood or blood components with the extracorporeal circuit will likely result in coagulation activation or even loss of coagulation factors. Citrate anticoagulation has gained popularity, especially in hemodialysis patients. It results in a highly effective anticoagulation, exclusively confined to the extracorporeal circulation. Moreover, dependent on the type of dialyser membrane, citrate anticoagulation resulted in reduced activation of other cellular components. In contrast to hemodialysis patients, experience with citrate anticoagulation during treatment with artificial liver devices is limited. The liver contributes substantially to the metabolism of exogenous citrate. As a result, cirrhotic patients have decreased endogenous citrate clearances. Importantly, blood purification devices contribute substantially to overall citrate clearance, thereby preventing accumulation of citrate. Several centres, including our own, have gained experience with citrate anticoagulation during fractionated plasma separation and adsorption (FPSA), a related liver dialysis device, in the treatment of liver failure patients. Citrate anticoagulation during MARS treatment has not been studied so far.

NCT ID: NCT00683748 Active, not recruiting - Clinical trials for Terminal Liver Failure

Monitoring Cellular Immunity After Kidney and Liver Transplantation

Start date: March 2007
Phase: N/A
Study type: Observational

After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.

NCT ID: NCT00670124 Completed - Clinical trials for Intracranial Hypertension

Hypothermia to Prevent High Intracranial Pressure in Patients With Acute Liver Failure

Start date: January 2005
Phase: N/A
Study type: Interventional

Treatment options in patients with high intracranial pressure due to acute liver failure are limited. This study intends to evaluate the effect of prophylactic hypothermia on preventing high intracranial pressure and compromised cerebral oxidative metabolism.

NCT ID: NCT00655707 Completed - Liver Disease Clinical Trials

A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency

Start date: January 2006
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective dose escalation study of the administration of adult human stem cells in patients with end stage liver failure. Successive groups of two patients will receive ascending doses of autologous adult human stem cells starting at 1x10[9] cells. Following expansion in an approved Good Manufacturing Practice (GMP) facility the cells will be infused into either the hepatic artery or portal vein of research participants. The aim of this trial is to determine the maximum tolerated dose of autologous adult stem cells when infused into either the hepatic artery or the portal vein. The maximum dose that would be given would be 5x10 to the ten [10]. To assess improvement in liver function as measured by serological and biochemical analysis and determine whether there are any symptomatic improvements as reported by the patients.

NCT ID: NCT00655304 Completed - Clinical trials for Hepatic Encephalopathy

The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure

Start date: March 2007
Phase: N/A
Study type: Interventional

The main objective of this study is to investigate the effect of Prometheus liver support dialysis on intracranial pressure, cerebral metabolism and circulation in patients with acute liver failure.