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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

RecruitingNAAges 18 Years - anyAllBayer
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 * โ‰ฅ3 coronary artery bypass grafts * Participant with: chronic kidney disease (CKD): 30 โ‰ค 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
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What it tests

  • No investigational study intervention
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Where

4 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Germany
Royal Papworth Hospital | Cardiac Surgery
Cambridge, United Kingdom
Harefield Hospital | Cardiology
Harefield, United Kingdom
St Thomas' Hospital | Critical Care
London, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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