LEAK: Lipocalin in the ED for the diagnosis of Acute Kidney injury
Research type
Research Study
Full title
A multicenter prospective cohort study of the diagnostic accuracy of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Cystatin C for Acute Kidney Injury (AKI) in consecutive adult patients admitted from the Emergency Department (ED).
IRAS ID
144916
Contact name
Manish Thakker
Contact email
Sponsor organisation
Royal Berkshire NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Acute kidney injury (AKI) is a condition where the kidneys start to fail in their ability to filter waste products from the body. It is detected by a fall in the urine volume as well as through blood tests showing rising levels of creatinine. Creatinine is excreted by the kidney. The problem is that AKI develops before a rise in the level of creatinine. Earlier recognition would allow treatment and further progression could be prevented with a number of different strategies. New tests are needed for this reason.
Neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin C are proteins produced in the blood and the kidneys in response to inflammation and kidney injury. They are thought to be one of the earliest markers for AKI. Currently there is not enough evidence to show that either test works in patients in the Emergency Department (ED) setting.
The main aim of the study is to establish how accurate NGAL and Cystatin C are compared to the markers we currently use for diagnosing AKI in the ED.
This study is going to include 950 consecutive adult patients admitted to the hospital from the EDs of the Royal Berkshire Hospital, Wexham Park Hospital, John Radcliffe Hospital and Milton Keynes University Hospital. A small sample of unused blood will be saved from the routine bloods taken on admission to run the new tests but this will only be done on all patients who have a repeat blood test 24-48 hours after admission.
Posters will be displayed to inform those attending the EDs that information collected during their care may be anonymised and used for research purposes. The poster includes contact details of the local study team should anyone have any questions or object to being included in the study.
The study recruitment will be run over 6 weeks.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0566
Date of REC Opinion
25 Sep 2015
REC opinion
Favourable Opinion