A Study to Understand How Post-operative Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine

Launched by BAYER · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how post-operative acute kidney injury (PO-AKI) develops in patients undergoing heart surgery with the use of a heart-lung machine. PO-AKI is a condition where the kidneys do not function properly after surgery, and certain factors, like age and pre-existing health conditions such as kidney disease or diabetes, can increase the risk. Researchers want to understand the early changes in the body that lead to PO-AKI by looking at specific biological markers in blood and urine samples before and after surgery. This could help them find better ways to treat and prevent this complication in the future.

To participate in this study, individuals must be at least 18 years old and scheduled for specific heart surgeries that involve a heart-lung machine. They should also have some level of chronic kidney disease. Participants will not receive any experimental treatments; they will go through their usual surgical care, and researchers will monitor their health and collect samples for analysis for up to 3.5 months. This study aims to gather important information that could lead to improved care for patients at risk of developing PO-AKI following heart surgery.

Gender

ALL

Eligibility 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) ≤ 75 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 3 months
• • Prior renal transplants or RRT
• • Planned use of contrast media prior/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.