Actively Recruiting
Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
Led by Guowei Tu · Updated on 2026-05-18
1491
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are examining new biomarkers found in blood and urine samples taken before and shortly after cardiac surgery to help predict kidney problems after surgery in patients at high risk. The study focuses on identifying factors that warn of acute kidney injury (AKI) after cardiac surgery and compares these novel markers with traditional ones. This observational study aims to improve early detection, preventive care, and overall safety in cardiac surgery outcomes. The project will collect medical history, lab data, and test specific biomarkers such as TWEAKR, galectin-9, perilipin-2, and CCN family member 1 from patients undergoing elective open chest cardiac surgery. Patients are categorized based on their risk factors and whether cardiopulmonary bypass (CPB) is used during surgery. A standard care "bundle" based on Kidney Disease Improving Global Outcome guidelines will be used to manage any AKI cases identified. Participants will be monitored for AKI occurrence within 7 days after surgery, which is the main outcome measured. Additional outcomes include AKI severity at various time points, major kidney events, need for kidney replacement therapy, mortality, ICU and hospital stay length, use of vasoactive drugs, and AKI in chronic kidney disease. The study involves collecting data and samples during the perioperative period to analyze these outcomes, with follow-up extending up to 30 days for mortality assessment.
CONDITIONS
Brief Title
Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients scheduled for elective open chest cavity cardiac surgery, with or without cardiopulmonary bypass (CPB)
- Patients undergoing surgery with CPB must have at least one acute kidney injury (AKI) risk factor
- Patients undergoing surgery without CPB must have at least two AKI risk factors
- AKI risk factors include age over 70 years, estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m2, diabetes mellitus, proteinuria, recent congestive heart failure, left ventricular ejection fraction of 40% or lower, prior cardiac surgery, combined coronary artery bypass/valve procedure, urgent procedure, or preoperative intra-aortic balloon pump
You will not qualify if you...
- Pre-existing chronic kidney disease with estimated glomerular filtration rate below 30 mL/min/1.73 m2
- Previous renal replacement therapy before cardiac surgery
- Present acute kidney injury at screening
- History of kidney transplant or other kidney diseases
- Known pregnancy
- Multiple operations during the hospital stay
- Being in a moribund state with an expected likelihood of death within 48 hours
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 - Perioperative period
Participants undergo elective open chest cavity cardiac surgery and receive immediate post-operative care, including management based on a standard care "bundle" for acute kidney injury (AKI) prevention.
1 surgical event and several in-hospital assessments
Duration - Up to 30 days post-surgery
Participants are monitored for the occurrence of AKI and other kidney-related outcomes, including moderate and severe AKI, renal replacement treatment, and major adverse kidney events.
Approximately 6 follow-up visits during hospital stay and up to 30 days
Trial Site Locations
Total: 2 locations
1
Zhongshan hospital, Fudan university
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
2
Zhongshan hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
G
Guo wei Tu, MD
Y
Ying Su, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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