Evaluation of an L-FABP Urine Device (ELUDe) V1
Research type
Research Study
Full title
A performance evaluation study of a point of care device for measurement of urinary L-FABP in diagnosis and monitoring prediction of kidney disease
IRAS ID
188328
Contact name
Sandip Mitra
Contact email
Sponsor organisation
Manchester NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Kidney injury following a major illness or surgery can affect one in five patients admitted to hospital and cause significant illness and death. If identified early it can be treated and further illness prevented. Liver type fatty-acid binding protein (L-FABP) is a test that can identify patients at risk of kidney injury. Although very accurate, its main limitation is the time that it takes laboratory analysis. A bedside test that can give a result within 15 minutes will be more effective. Such a test can also be used in kidney clinics to identify early patients with worsening kidney injury and enable doctors to focus their efforts in preventing that.
We aim to assess the how accurate this bed-side test is compared to the laboratory test for L-FABP.
Three participant groups will be studied. One will consist of 500 patients admitted to Central Manchester University Hospitals (CMFT) with an acute illness. They will have a urine sample tested for L-FABP with both the bed-side test and at the laboratory within 24hrs of admission. Their records will then be monitored for the duration of their stay in hospital or one month for the development of kidney injury.
The second group would be a high-risk group for developing kidney injury and would consist of 80 patients having bone marrow transplantation at CMFT. They will have 3-4 urine samples tested with both tests at set time points before and after their transplantation. Their record will then be monitored for one month for the development of kidney injury.
The third group would consist of 500 patients with chronic kidney disease attending the kidney clinic at CMFT. They will have a urine sample tested with both tests during their attendance to clinic. Their record will then be monitored for one year for kidney injury development.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0516
Date of REC Opinion
15 Jan 2016
REC opinion
Further Information Favourable Opinion