Understanding how kidney injury develops after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Herz- und Diabeteszentrum Nordrhein-Westfalen
  Bad Oeynhausen, North Rhine-Westphalia, Germany Recruiting
• Royal Papworth Hospital | Cardiac Surgery
  Cambridge, Cambridgeshire, United Kingdom Recruiting
• Harefield Hospital | Cardiology
  Harefield, Greater London, United Kingdom Recruiting
• St Thomas' Hospital | Critical Care
  London, Greater London, United Kingdom Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BX-001N to prevent kidney injury after cardiac surgery with total circulatory arrest

  This study will see if BX-001N can prevent acute kidney injury and later major kidney problems in adults undergoing cardiac surgery with total circulatory arrest.

  Recruiting at 5 sites Phase 2 Bilix Co.,Ltd. · Daegu and 7 other locations · NCT07164833

• Using ultrasound to prevent and treat kidney injury after heart surgery

  This study is testing if using ultrasound to check for fluid buildup in the liver and kidneys can help prevent and treat kidney problems after heart surgery.

  Recruiting Onassis Cardiac Surgery Centre · Athens, Kallithea · NCT06972082

• Kidney-surface versus limb NIRS monitoring to predict acute kidney injury after cardiac surgery with bypass

  This study will try NIRS sensors placed over the kidneys versus on the limbs to see which better predicts acute kidney injury in adults having cardiac surgery with cardiopulmonary bypass.

  Recruiting University of Utah · Salt Lake City, Utah · NCT06705855

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.