AKI-Diagnostics
Research type
Research Study
Full title
The future for diagnostic tests of acute kidney injury in critical care: evidence synthesis, care pathway analysis and research prioritisation.
IRAS ID
172848
Contact name
Peter Hall
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 7 months, 11 days
Research summary
Acute kidney injury (AKI) is when damage occurs to the kidneys, often leading to impairment in their life-sustaining function. AKI has recently been highlighted by NICE as a major problem for public health. NICE estimate that acute kidney injury costs the NHS £434—620 million every year; more than do breast, lung, and skin cancer combined. According to NICE, adequate care of acute kidney injury could avoid 42 000 deaths every year.
AKI occurs in up to 70% of critically ill patients. Patients who develop AKI have worse clinical outcomes with a mortality rate greater than 50% which, despite advances in modern medicine, has remained unchanged for the last 30 years. Patients who develop AKI in the UK stay in hospital an average of 4.7 days longer than patients without AKI. Patients who develop severe AKI requiring dialysis have a further increase in their risk of death. More recently it has been recognised that chronic kidney disease occurs in 40% of survivors of AKI in critical illness and results in significant health problems and expense. Up to 10% of all patients who experience AKI will not recover sufficient kidney function and will remain on life-long dialysis or require a kidney transplant. Chronic kidney disease in the UK costs £1.45 billion per year.
For these reasons it is important to identify patients who are developing AKI in order to treat them earlier or more intensively and limit subsequent problems as much as possible. The diagnosis of AKI can be difficult; even with the best test we currently have (serum creatinine) AKI may not become apparent until several days after the kidneys have started to be damaged. There is currently no single test that can immediately diagnose AKI or tell us how severe it will become, however, there are several tests in development both in academia and by industry that offer this potential. A number of biomarkers have already been commercialised as in-vitro diagnostic test kits and are subject to active marketing campaigns. There is therefore a real risk that these tests could be adopted by NHS laboratories and clinicians prior to the development of robust supporting evidence for clinical and cost effectiveness.
This study will:
1. Identify tests currently in development
2. Characterise the scientific evidence supporting the most promising tests
3. Describe the care pathway followed by patients in critical care who are at risk of AKI, including what happens to them in hospital and after discharge (long-terms complications, healthcare costs, quality of life, survival)
4. Develop a mathematical model representing the care pathway
5. Use the model to work out how and where the various tests can potentially improve care
6. Recommend if tests are ready to improve the cost-effectiveness of NHS care now, or if further research is required.
7. Recommend further research for the development of evidence for diagnostic tests for AKI.
The results of the project not only inform NHS clinicians and commissioners, but will also feed into a UK national programme of research into diagnostic tests for AKI in both the academic and commercial sectors supported by NIHR infrastructure organisations. These results will provide an opportunity to avoid the mistakes made in the development of personalised medicine strategies in other diseases by designing an efficient development plan early on, thus avoiding wasted research funding and speeding up the time for tests to reach the patients in need.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0163
Date of REC Opinion
14 Apr 2015
REC opinion
Favourable Opinion