Predicting kidney injury after high-risk heart surgery using new blood and urine biomarkers

Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients

This project will test whether new blood and urine biomarkers can help predict which high-risk adults having open-chest cardiac surgery will develop acute kidney injury.

Quick facts

• Study type: Observational
• Enrollment: 1491 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07418242 on ClinicalTrials.gov

What this trial studies

This prospective observational project will enroll high-risk adults undergoing elective open‑chest cardiac surgery at Zhongshan Hospital and collect preoperative and early postoperative blood and urine samples. Researchers will measure candidate biomarkers such as TWEAKR, Galectin-9, Plin2, and CCN1 alongside routine clinical and laboratory data. The primary endpoint is occurrence of postoperative acute kidney injury, and statistical methods (including logistic regression) will be used to identify early predictors and compare performance with traditional markers. Findings aim to define biomarker signatures that could provide earlier warning of renal risk after cardiac surgery.

Who should consider this trial

Good fit: Adults scheduled for elective open-chest cardiac surgery at Zhongshan Hospital who meet the study's AKI risk criteria (at least one risk factor if on cardiopulmonary bypass or at least two if not) and who do not have severe preexisting renal failure or current AKI.

Not a fit: Patients with advanced chronic kidney disease (preoperative eGFR <30 mL/min/1.73 m2), those already on renal replacement therapy, or those with active preoperative AKI are excluded and unlikely to benefit from these predictive biomarkers.

Why it matters

Potential benefit: If successful, earlier identification of patients at risk for postoperative AKI could allow preventive measures and reduce complications after cardiac surgery.

How similar studies have performed: Other biomarker panels (for example NGAL and TIMP-2·IGFBP7) have shown mixed but promising results for early AKI prediction, while the specific markers studied here (TWEAKR, Gal-9, Plin2, CCN1) are relatively novel and less well validated clinically.

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).

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Zhongshan hospital, Fudan university — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Zhongshan hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Guo wei Tu, MD

Conditions Cardiac Surgery Associated - Acute Kidney Injury; Critical Illness; Acute kidney injury; Biomarker; Poor outcome; AKI occurrence; Prognostic value