Biomarkers of acute kidney injury recovery
Research type
Research Study
Full title
Identification and validation of biomarkers of acute kidney injury recovery
IRAS ID
132435
Contact name
Marlies Ostermann
Contact email
Research summary
Acute kidney injury (AKI) is a serious problem affecting about 30 - 50% patients in the Intensive Care Unit (ICU). There is increasing evidence that patients who have had severe AKI are at increased risk of chronic kidney damage in the following years, including needing long-term dialysis. For clinicians, one of the difficult challenges is to predict which patient with severe AKI is likely to recover renal function and which patient won’t and may benefit from more aggressive management.
The objective of this study is to collect blood and urine samples from patients with moderate or severe AKI to identify and validate new biomarkers which may predict renal recovery. Biomarkers are substances (i.e. proteins) in blood and urine that are indicators of a disease process occuring.
This study will enroll approximately 300 adult ICU patients from 20 hospitals in Europe and the United States with moderate or severe AKI. With informed consent blood and urine samples will be collected twice daily for the first 3 days and then daily for another 4 days. The samples will be collected, processed and stored in freezers and later transferred to the study sponosor Astute for analysis. Data available in the patient’s hospital record will be collected for analysis.
There will be no change in clinical management. The primary outcome of interest is renal recovery from AKI within several days to a week. Secondary outcomes are major cardiac and major renal events like mortality, myocardial infarct or ongoing need for dialysis at 30 and 90 days.
In an optional study, we also invite patients to donate blood and urine samples for measurement of inflammatory cells and inflammatory substances related to AKI.
We hope that the results of these studies will inform clinicians which patients need special management including follow-up after discharge from ICU.
REC name
London - Queen Square Research Ethics Committee
REC reference
13/LO/0932
Date of REC Opinion
30 Sep 2013
REC opinion
Further Information Favourable Opinion