NCT07418242

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,491 (estimated)
• Sponsor: Guowei Tu · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This project will prospectively collect all high-risk individuals who underwent cardiac surgery, collect medical history, laboratory data and specimen test results, and test biomarkers in blood and urine specimens. Previously identified candidate biomarkers include the tumor necrosis factor-like weak inducer of apoptosis receptor (TWEAKR), galectin-9 (Gal-9), perilipin-2 (Plin2), and CCN family member 1, among others. The occurrence of postoperative AKI will be the primary endpoint of the study. The variable factors that can be used to predict and warn the main research endpoints at an early stage were screened through methods such as logistic regression, and their non-inferiority compared with traditional markers was tested. This study will facilitate early clinical identification and early warning of AKI, early implementation of preventive measures and intervention strategies, thereby improving the prognosis of patients and improve the overall safety and success rate of cardiac surgery.

Conditions

• Cardiac Surgery Associated - Acute Kidney Injury
• Critical Illness

Interventions

Type	Name	Description
OTHER	Standard care "bundle"	The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.

Timeline

• Start date: 2026-02-23
• Primary completion: 2028-12-31
• Completion: 2029-05-31
• First posted: 2026-02-18
• Last updated: 2026-02-24

Locations

2 sites across 1 country: China