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Liver Failure clinical trials

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NCT ID: NCT01575015 Terminated - Liver Failure Clinical Trials

Intraoperative Dialysis in Liver Transplantation

INCEPTION
Start date: May 2012
Phase: N/A
Study type: Interventional

Patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. These patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. As a consequence, these patients are at an increased risk for complications related to their kidney failure during their liver transplantation procedure. One potential method to diminish the risk of these complications is to provide dialysis support to these patients during their liver transplantation in the operating theater in the form of continuous renal replacement therapy (CRRT). While this is increasingly being performed and is theoretically appealing, there is very little information to support this practice. In addition, the use of CRRT during surgery is not entirely without risk. The investigators have performed two preliminary studies on the use of CRRT during liver transplantation and our data would strongly support the need to conduct further higher-quality studies to better evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial comparing the use of CRRT during surgery with standard supportive care in sick patients with liver failure scheduled to receive a liver transplantation.

NCT ID: NCT01548690 Completed - Acute Liver Failure Clinical Trials

Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury

STOP-ALF
Start date: June 2012
Phase: Phase 2
Study type: Interventional

This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: - safety and tolerability; - metabolism of the compound to glutamine and phenylacetylglutamine (PAGN); - its effect on circulating ammonia levels and neurological function in patients with and without impaired renal function after continuous infusion at different infusion rates. Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day follow-up visit post infusion. It is anticipated that this early safety and tolerability study, with appropriate PK/PD data, will lead to a development program for the use of OCR-002 in the treatment of hyperammonemia either due to ALF or possibly other liver conditions. The hypotheses are: - Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune hepatitis, viral hepatitis or indeterminate etiologies. - A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations within 6-12h with little additional accumulation in the ALI/ALF setting. - Treatment with OCR-002 will reduce ammonia and improve neurological function in patients with acute liver failure/severe acute liver injury.

NCT ID: NCT01475136 Completed - Clinical trials for Hepatic Insufficiency

A Study of LY2140023 in Hepatically-Impaired Participants

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).

NCT ID: NCT01471262 Enrolling by invitation - Complications Clinical Trials

Right Hepatectomy in Patients Beyond 70 Years Old

Start date: January 2006
Phase: N/A
Study type: Observational

As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.

NCT ID: NCT01452295 Withdrawn - Acute Liver Failure Clinical Trials

Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.

NCT ID: NCT01435421 Not yet recruiting - Acute Liver Failure Clinical Trials

Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery

Start date: October 2011
Phase: N/A
Study type: Observational

Acute liver failure (ALF) results from an abrupt loss of hepatic metabolic and synthetic function and leads to encephalopathy and potentially multi-organ dysfunction. Aetiologies include autoimmune and metabolic diseases, infectious agents and hepatotoxins. Worldwide, infectious hepatitis (A, B and E) is the most common cause. In Western Europe and the USA, ALF is most frequently caused by paracetamol intoxication. The MBT can produce immediate results to aid in decision making in patients with acute liver disease. Such a test may affect decision-making regarding transplantation in this setting, facilitate appropriate discharge from critical care to other hospital units and to home, provide point of care assessment of therapeutic interventions. The BreathID can potentially help in determining: - Parameter to include patients in transplant list (the UNOS 1A group) - Identification that patient deteriorates and needs extended hospitalization/referral to ICU/change in management - An addition to the MELD and or other scores to estimate risk in other acute patients - Additional information to that of other commonly utilized prognostic scoring systems The primary end-point of the study is to develop a model to predict deterioration of the liver disease, which incorporates measurements from the MBT along with other potential variables. The data collected will be used to develop a prediction model using data-mining methodology (linear and non-linear regression models, binary trees, neural networks, etc…). The predictive models may include measurements from the MBT, blood test results, as single measurements or as trend over time. The model that will be developed, will attempt to predict the disease deterioration vs. recovery accurately, at an earlier time point than the standard procedure. A threshold will then be determinate based on adequate sensitivity and specificity levels.

NCT ID: NCT01429038 Completed - Kidney Failure Clinical Trials

Mesenchymal Stem Cells After Renal or Liver Transplantation

Start date: February 1, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The immune system of a patient can attack the liver or the kidney received from a donor (organ rejection). This can be prevented by treating these patients long-life with immunosuppressive drugs. Unfortunately, these drugs lead to numerous side effects and fail to prevent the rejection occurring months later after the transplantation (chronic rejection). Recently, it has been shown that a particular type of cells present in the bone marrow, namely Mesenchymal Stem Cells (MSC), when injected to a patient, suppress its immune system and increase success rates of blood cells transplantation. This outcome opens doors to investigate the potential of these cells to provide a valuable tool for improving solid organ transplantation without the need of high concentration of immunosuppressive drugs. The present project aims at evaluating the safety and tolerability of MSC administration after liver or kidney transplantation.

NCT ID: NCT01425385 Completed - Clinical trials for Liver Transplantation

Autoregulation Assessment During Liver Transplantation

Start date: September 2011
Phase: N/A
Study type: Observational

Patients with liver failure undergoing liver transplantation often have clinical or sub-clinical encephalopathy that may lead to increased intracranial pressure. The latter may lead to abnormal regulation of blood flow to the brain (cerebral autoregulation) complicating patient management during and after general anesthesia. The current methods for monitoring for elevated intracranial pressure are invasive and, thus, limited to severe encephalopathy. In this study the investigators will evaluate the potential utility of monitoring cerebral blood flow (CBF) autoregulation non-invasively using near infra-red spectroscopy in patients undergoing liver transplantation.

NCT ID: NCT01423708 Recruiting - Liver Cirrhosis Clinical Trials

Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

EPOCAL
Start date: February 2010
Phase: Phase 2
Study type: Interventional

Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.

NCT ID: NCT01404793 Completed - Liver Failure Clinical Trials

SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation

Start date: September 2011
Phase: N/A
Study type: Observational

Standard anesthetic management of liver transplantation patients includes a general anesthetic using multiple drugs, including the neuromuscular relaxant rocuronium. Pharmacokinetic modelling of this agent has been poorly described during liver transplantation, which impacts on appropriate dosing of this agent within this population where plasma concentrations can vary with fluid shifts and hepatic drug metabolism during the various phases of liver transplantation. Plasma drug and drug metabolite concentrations will be measured using the technique of solid phase micro-extraction (SPME). Measuring and correlating the levels of rocuronium and other liver metabolites with the degree of post transplantation hepatic dysfunction may serve as a simple and cost-effective marker to aid diagnosis, identify those at risk of hepatic dysfunction and potentially grade the severity