Actively Recruiting
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Led by Bayer · Updated on 2026-04-30
200
Participants Needed
4
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are looking for a better way to treat and prevent cardiac surgery-associated acute kidney injury (CSA-AKI) in people who undergo heart surgeries. CSA-AKI is a common complication in people undergoing heart surgeries, where the kidneys stop working properly. CSA-AKI risk factors include older age and alongside diseases such as kidney disease and diabetes. Longer time with heart-lung machine during heart surgeries also increases the occurrence of CSA-AKI. In this study, researchers want to better understand how CSA-AKI develops (also known as the mechanisms involved in the development of CSA-AKI) in people under heart surgeries, the presence of certain biomarkers in the body, especially with a focus on the early hours and days after the surgery. (A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.) These biomarkers will be compared in participants who develop CSA-AKI within a week after heart surgery with the participants who do not develop CSA-AKI. The relationship with biomarkers will be determined by examining participants' blood and urine samples before and after surgery. This may help researchers better understand CSA-AKI, identify potential treatment targets and develop possible treatments to prevent CSA-AKI. Participants in this study will be people who have heart surgery already scheduled by their own doctors and have a risk of developing CSA-AKI. Participants will not receive any treatment as part of this study. They will undergo the heart surgery and related medical processes as per their normal medical treatment and management. Each participant will be in the study for up to 2 months. During the study, the doctors and their study team will: * collect participants' blood and urine samples before and after surgery * assess participants' medical records and test reports during hospitalization * monitor overall health of the participants throughout the study
CONDITIONS
Official Title
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 18 years of age at the time of signing the informed consent form.
- Scheduled for cardiovascular surgery involving cardiopulmonary bypass, including aortic, mitral, or tricuspid valve surgery (repair or replacement), aortic surgery, or 3 or more coronary artery bypass grafts.
- Has chronic kidney disease with an estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m².
You will not qualify if you...
- Emergency surgery situation.
- Anemia with hemoglobin less than 10 g/dL.
- Clinical signs of systemic infection or other infection needing anti-infective treatment (single-dose prophylaxis allowed).
- Receiving systemic immunosuppressive or anti-inflammatory treatment including corticosteroids over 10 mg prednisolone equivalent per day.
- Any anti-cancer treatment within the last 3 months.
- Major surgery within the last 2 months.
- Acute kidney injury within the last month.
- Prior renal transplants or renal replacement therapy.
- Planned use of contrast media within 5 days before or during surgery.
- Participation in another interventional clinical trial involving pharmacological treatment.
- Any condition making participation unadvisable as decided by the investigator.
- Autoimmune disorders such as anti-glomerular basement membrane diseases, systemic lupus erythematosus, chronic rheumatic heart diseases, acute rheumatic heart pericarditis, endocarditis, myocarditis, rheumatic mitral valve diseases, or rheumatic aortic valve diseases.
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Trial Site Locations
Total: 4 locations
1
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Actively Recruiting
2
Royal Papworth Hospital NHS Foundation Trust | Royal Papworth Hospital - Cardiac Surgery
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
Actively Recruiting
3
Guy's and St Thomas' NHS Foundation Trust | Harefield Hospital - Cardiology
Harefield, Greater London, United Kingdom, UB9 6JH
Not Yet Recruiting
4
Guy's and St Thomas' NHS Foundation Trust | Guy's & St Thomas' Hospital - Department of Critical Care & Nephrology
London, Greater London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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