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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Cardiac Surgery Associated - Acute Kidney Injury
• Intervention / Treatment: Other: Standard care "bundle"

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.

• Study Type: Observational
• Enrollment (Estimated): 1491

Contacts and Locations

• Study Contact: Name: Ying Su, MD; Phone Number: +86 021 64041990; Email: su.ying@zs-hospital.sh.cn
• Study Contact Backup: Name: Guo wei Tu, MD; Phone Number: 86-021-64041990; Email: tu.guowei@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Zhongshan Hospital
    • Shanghai, Shanghai Municipality, China, 200030
      • Not yet recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Guo Wei Tu, MD; Phone Number: +86-021-64041990; Email: tu.guowei@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All high-risk AKI patients who underwent cardiac surgery at Zhongshan Hospital Affiliated to Fudan University.CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI occurrence within 7 days	AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality at 30 days	30 days
AKI occurrence within 3 days	AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.	3 days
AKI occurrence within 48 hours	AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.	48 hours
length of stay in the ICU	length of stay in the ICU	Perioperative
Length of stay in the hospital	Length of stay in the hospital	Perioperative
The number of days of use and cumulative dose of vasoactive drugs	The number of days of use and cumulative dose of vasoactive drugs during ICU stay.	Perioperative
AKI on CKD	Number of patients with CKD develop AKI after surgery	Perioperative
Moderate and severe AKI occurrence within 7 days	Stage 2 and stage 3 AKI based on KDIGO criteria.	7 days
Major adverse kidney events	MAKE at discharge MAKE was defined as the composite of≥25% loss in estimated glomerular filtration rate (eGFR), dialysis, or death. Estimated GFR was calculated from serum creatinine using the MDRD equation.	Perioperative
Receipt of renal replacement treatment	Patients received renal replacement therapy after being diagnosed with AKI.	Perioperative

Collaborators and Investigators

• Sponsor: Guowei Tu
• Investigators: Study Director: Zhe Luo, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Biomarker; Acute kidney injury; Prognostic value; Poor outcome; AKI occurrence; Cardiac Surgery Associated - Acute Kidney Injury
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: B2025-549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No