Cardiac Output optimisation following Liver Transplantation (COLT) Trial
Research type
Research Study
Full title
A feasibility study of Cardiac Output optimisation following Liver Transplantation (COLT trial)
IRAS ID
180463
Contact name
Brian Davidson
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN10329248
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Liver transplantation is currently the mainstay of treatment for liver failure and more than 800 liver transplants are performed each year in UK. Liver transplantation is associated with a high risk of postoperative complications; 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.\n\nFollowing other types of major surgery a machine and protocol has been used to determine the amount of intravenous (IV) fluid required (goal directed fluid therapy – GDFT). GDFT has been shown to markedly reduce the incidence of postoperative complications. It is not known whether this method of treating patients is beneficial or harmful following liver transplantation because these patients differ enormously by having liver cirrhosis. Results on GDFT from other types of surgery may not be applicable.\n\nThe proposed feasibility study will be the first trial to assess the practicability and safety of GDFT following liver transplantation. Participants will be randomised to receive either GDFT or standard current management of IV fluids for the first 12 hours postoperatively. We shall assess how many patients are willing to join the study and how many can tolerate the machine guided fluid therapy. We will also obtain preliminary information on whether GDFT is harmful or beneficial and determine which outcomes should be measured if a larger trial is required to prove benefit.\n\nThe study will be conducted at the Royal Free Hospital, a national liver transplantation centre that performs approximately 100 liver transplants per year. We aim to recruit 50 patients into this study and follow patients up for six months post transplant.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1824
Date of REC Opinion
5 Jan 2016
REC opinion
Further Information Favourable Opinion