Actively Recruiting
Methodology Study in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass to Investigate Mechanisms Involved in Cardiac Surgery-associated Acute Kidney Injury
Led by Bayer · Updated on 2026-06-01
200
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how cardiac surgery-associated acute kidney injury (CSA-AKI) develops in people undergoing heart surgeries with the use of a heart-lung machine. CSA-AKI is a common problem after such surgeries, especially in older adults and those with kidney disease or diabetes. The study aims to understand the biological mechanisms behind CSA-AKI by examining specific biomarkers in blood and urine samples taken before and after surgery. Participants scheduled for heart surgery involving cardiopulmonary bypass will receive their usual medical care. No experimental treatments will be given. Blood and urine samples will be collected before and after surgery to analyze biomarkers. The study focuses on comparing those who develop CSA-AKI within a week after surgery with those who do not. During the up to 2-month study period, researchers will monitor participants' overall health, review medical records, and collect laboratory test results from hospitalization. The primary outcome is the number of participants developing CSA-AKI within 3 days post-surgery. Secondary outcomes include changes in biomarker levels up to 7 days after surgery, helping to identify potential targets for prevention or treatment of CSA-AKI.
CONDITIONS
Brief 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 hospital admission for cardiovascular surgery involving cardiopulmonary bypass, including aortic, mitral, or tricuspid valve surgery, aortic surgery, or at least 3 coronary artery bypass grafts.
- Chronic kidney disease with 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 requiring anti-infective treatment (single-dose prophylaxis allowed).
- Systemic immunosuppressive or anti-inflammatory treatment including corticosteroids greater than 10 mg prednisolone equivalent per day.
- Any anti-cancer treatment within 3 months.
- Major surgery within 2 months.
- Acute kidney injury within the last month.
- Prior renal transplants or renal replacement therapy.
- Planned use of contrast media within 5 days prior to or during surgery.
- Participation in an interventional clinical trial involving a pharmacological intervention.
- Any reason making participation unadvisable, at investigator's discretion.
- Autoimmune disorders such as anti-glomerular basement membrane diseases, systemic lupus erythematosus, chronic rheumatic heart diseases, acute rheumatic heart pericarditis, endocarditis, myocarditis, rheumatic mitral or aortic valve diseases.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo cardiac surgery with cardiopulmonary bypass as part of their routine medical care.
1 surgery visit (in-person)
Duration - Up to 7 days post-surgery
Blood and urine samples are collected before and after surgery to analyze biomarkers related to cardiac surgery-associated acute kidney injury.
Several visits for sample collection and monitoring within 7 days post-surgery
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
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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