Understanding how kidney injury develops after heart surgery
Methodology Study in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass to Investigate Mechanisms Involved in Cardiac Surgery-associated Acute Kidney Injury.
NA · Bayer · NCT06772025
This study is trying to understand how kidney injury happens after heart surgery in patients who use a heart-lung machine, to help improve care for this common problem.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer (industry) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 4 sites (Bad Oeynhausen, North Rhine-Westphalia and 3 other locations) |
| Trial ID | NCT06772025 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the mechanisms behind post-operative acute kidney injury (PO-AKI) in patients undergoing heart surgery with the use of a heart-lung machine. Researchers will analyze biomarkers in participants who develop PO-AKI within a week after surgery, focusing on the early hours and days post-operation. The study will include patients scheduled for specific cardiovascular surgeries involving cardiopulmonary bypass, and will not involve any investigational treatments. By understanding the development of PO-AKI, the study seeks to improve treatment and prevention strategies for this common complication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for specific cardiovascular surgeries involving cardiopulmonary bypass and with chronic kidney disease.
Not a fit: Patients undergoing emergency surgeries or those with severe anemia or systemic infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prevention and treatment strategies for post-operative acute kidney injury in heart surgery patients.
How similar studies have performed: While the study focuses on understanding mechanisms of PO-AKI, similar studies have shown promise in identifying risk factors and biomarkers related to kidney injury in surgical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must be at least 18 years of age at the time of signing the informed consent form (ICF). * Participants who are scheduled for hospital admission for any of the following cardiovascular surgery interventions, alone or in combination, involving cardiopulmonary bypass (CPB): * Aortic, mitral, or tricuspid valve surgery (repair or replacement) * Aortic surgery * ≥3 coronary artery bypass grafts * Participant with: chronic kidney disease (CKD): 30 ≤ estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m\^2 Exclusion Criteria: * Emergency surgery situation * Anemia - hemoglobin \<10 g/dL * Clinical signs of systemic infection or other infection requiring anti-infective treatment (viral, bacterial, fungal, parasitic; single-dose prophylaxis allowed) * Systemic immunosuppressive or anti-inflammatory treatment including corticosteroids \>10 mg prednisolone equivalent/day * Any anti-cancer treatment within 3 months (e.g. immunotherapy, chemotherapy, radiotherapy) * Major surgery within 2 months * AKI within the last month * Prior renal transplants or RRT * Planned use of contrast media within 5 days prior to surgery or during surgery * Patient included in an interventional clinical trial involving a pharmacological intervention * Any reason that would make participation unadvisable, at the discretion of the investigator. * Autoimmune disorders such as anti-glomerular basement membrane (anti-GBM) diseases, systemic lupus erythematosus, chronic rheumatic heart diseases, acute rheumatic heart pericarditis, endocarditis, myocarditis, rheumatic mitral valve diseases, rheumatic aortic valve diseases
Where this trial is running
Bad Oeynhausen, North Rhine-Westphalia and 3 other locations
- Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) — Bad Oeynhausen, North Rhine-Westphalia, Germany (RECRUITING)
- Royal Papworth Hospital NHS Foundation Trust | Royal Papworth Hospital - Cardiac Surgery — Cambridge, Cambridgeshire, United Kingdom (RECRUITING)
- Guy's and St Thomas' NHS Foundation Trust | Harefield Hospital - Cardiology — Harefield, Greater London, United Kingdom (NOT_YET_RECRUITING)
- Guy's and St Thomas' NHS Foundation Trust | Guy's & St Thomas' Hospital - Department of Critical Care & Nephrology — London, Greater London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Surgery-associated Acute Kidney Injury, CSA-AKI, Cardiac surgery, Cardiopulmonary bypass