Extrait

Background and study aims Cirrhosis is a serious complication of liver disease, which involves widespread scarring of the liver. The damage to the liver caused by cirrhosis means that eventually the liver is unable to fulfil its normal functions, ultimately leading to liver failure. Cirrhosis develops gradually, however the damage to the liver is irreversible, and gets worse over time. When cirrhosis is so advanced that the liver is unable to function, a liver transplant is the only treatment option. Liver transplantation is currently the mainstay of treatment for liver failure and more than 800 liver transplants are performed each year in UK. Although a lifesaving treatment, liver transplantation is linked with a high risk of postoperative complications, and nearly two thirds of patients develop serious complications such as failure of the heart and lungs, loss of kidney function, infection, blood clots, or bleeding. Complications such as these can increase a patient’s length of hospital stay, decrease their quality and length of life and result in failure of the transplanted organ, or even death. Following other types of major surgery goal directed fluid therapy (GDFT) is used in order to determine the amount of intravenous (through a drip) fluid needed by the patient. GDFT has been shown to markedly reduce the occurrence of postoperative complications. It is not known whether this method of treating patients is beneficial or harmful following liver transplantation because the fact that these patients have liver cirrhosis means that their bodies process things differently. The aim of this study is to assess the practicability and safety of GDFT following liver transplantation. Who can participate? Adults with liver cirrhosis who have been selected to have a liver transplant. What does the study involve? Participants are randomly allocated to one of two groups. Participants in the first group receive GDFT for 12 hours after their transplant surgery. This involves using a device to measure the volume of blood ejected by the heart at each beat (stroke volume), which is used to determine whether IV fluid should be given to the patient, according to a commonly used method for surgical patients. Participants in the second group are treated using the standard current management of IV fluids (drips) for the first 12 hours after surgery. Participants in both groups are followed up after six months to find out if the new liver is working properly and there have been any complications after the transplant, as well as their quality of life and length of stay in hospital after the surgery. What are the possible benefits and risks of participating? There are no direct benefits for participants taking part in this study. In most studies, goal directed fluid therapy has been shown to be of benefit to patients undergoing surgery. Goal directed fluid therapy has never been evaluated in patients following liver transplantation, and we shall closely assess its safety in this setting. There are no notable risks involved with participating in this study. Where is the study run from? Royal Free Hospital (UK) When is the study starting and how long is it expected to run for? May 2014 to October 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Daniel Martin

Critère d'inclusion

• Liver transplantation for liver cirrhosis

Liens

• ictrp
• isrctn