Methodology study in PO-AKI v1.0
Research type
Research Study
Full title
Methodology study in patients undergoing cardiac surgery with cardiopulmonary bypass to investigate mechanisms involved in post-operative acute kidney injury
IRAS ID
343231
Contact name
Kai Riecke
Contact email
Sponsor organisation
Bayer AG
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Post-operative Acute Kidney Injury (PO-AKI) is a well-documented complication of major surgery. It is particularly frequent (one in 3-4 patients) after cardiac surgery using cardiopulmonary bypass ("on pump"). It is strongly associated with long-term adverse outcomes, including the risk of chronic kidney disease (CKD), cardiovascular events and death. PO-AKI can result in extended intensive care treatment and hospitalization and may require renal replacement therapy (dialysis).
In absence of approved drugs, there is an unmet medical need for new treatments to prevent and treat PO-AKI and long-term adverse outcomes, eg CKD.
The purpose of this study is to investigate the relationships between the development of PO-AKI and the time course of suspected biomarkers of pathways (or biological processes) leading to the condition, and to uncover potential new pathways. This information will support the development of new therapies.This study is sponsored by Bayer AG. It will enrol patients having routine cardiac surgery at Royal Papworth and Harefield hospitals in the UK and at one hospital in Germany. It is anticipated to start in September 2024 and complete in 6 months. There is no intervention in normal clinical care for the patients, other than a small number of extra blood samples prior to and for up to 2 weeks after surgery, so minimal risk. Individual patients will not benefit from participation.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0208
Date of REC Opinion
18 Jul 2024
REC opinion
Further Information Favourable Opinion