NCT07418242 Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
| NCT ID | NCT07418242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guowei Tu |
| Condition | Cardiac Surgery Associated - Acute Kidney Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,491 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,491 participants in total. It began in 2026-02-23 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Zhe Luo, MD
STUDY DIRECTOR
Fudan University
Frequently Asked Questions
Who can join the NCT07418242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Cardiac Surgery Associated - Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07418242 currently recruiting?
Yes, NCT07418242 is actively recruiting participants. Contact the research team at tu.guowei@zs-hospital.sh.cn for enrollment information.
Where is the NCT07418242 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07418242 clinical trial?
NCT07418242 is sponsored by Guowei Tu. The principal investigator is Zhe Luo, MD at Fudan University. The trial plans to enroll 1,491 participants.
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