Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients (NCT07418242) | Clinical Trial Compass
RecruitingNot Applicable
Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
China1,491 participantsStarted 2026-02-23
Plain-language summary
This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adult patients were included in the study if they were scheduled for elective open chest cavity cardiac surgeries, with or without the use of cardiopulmonary bypass (CPB). Inclusion criteria required that patients undergoing surgery with CPB must have at least one AKI risk factor, whereas those undergoing surgery without CPB needed to have at least two AKI risk factors.
The AKI risk factors were as follows:
* age \>70 years;
* 30 \< estimated glomerular filtration rate (eGFR) \<60 mL·min-1·1.73 m-2;
* diabetes mellitus, proteinuria;
* a history of congestive heart failure within the previous year;
* a left ventricular ejection fraction of 40% or lower;
* prior cardiac surgery;
* combined coronary artery bypass/valve procedure;
* urgent procedure;
* preoperative intra-aortic balloon pump.
Exclusion criteria:
* pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2);
* previous RRT before cardiac surgery;
* present AKI at screening;
* a history of kidney transplant or other kidney diseases;
* known pregnancy;
* multiple operation during the hospital stay;
* being in a moribund state (with an anticipated likelihood of death within 48 hours).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on studying biomarkers to predict kidney injury after cardiac surgery — does my specific type of cardiac surgery put me at higher risk for AKI, and would participating in this study give me any additional monitoring I wouldn't otherwise receive?
2Since this is a biomarker observation study rather than a treatment trial, what exactly would be asked of me as a participant — for example, would there be extra blood draws or tests beyond what my standard care already involves?
3The study is tracking whether acute kidney injury occurs within 7 days of surgery — if the researchers detect warning signs in my biomarkers during that window, would my care team be notified and would it change how I'm managed?
4Given that this trial is categorized as 'not applicable' for phase, meaning it's not testing a new drug or device, how does joining this study affect my standard post-surgical care, and is there any reason it might be better for me to focus entirely on my recovery instead?
5Are there other hospitals or patients being enrolled in this trial, and does my overall kidney health going into surgery affect whether this kind of biomarker monitoring would be relevant or useful for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.