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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07418242
Enrollment
1491
Registered
2026-02-18
Start date
2026-02-23
Completion date
2029-05-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Associated - Acute Kidney Injury, Critical Illness

Keywords

Acute kidney injury, Biomarker, Poor outcome, AKI occurrence, Prognostic value, Cardiac Surgery Associated - Acute Kidney Injury

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.

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.

Interventions

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

Sponsors

Guowei Tu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion 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).

Design outcomes

Primary

MeasureTime frameDescription
AKI occurrence within 7 days7 daysAKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Secondary

MeasureTime frameDescription
Moderate and severe AKI occurrence within 7 days7 daysStage 2 and stage 3 AKI based on KDIGO criteria.
AKI occurrence within 48 hours48 hoursAKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
AKI occurrence within 3 days3 daysAKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Major adverse kidney eventsPerioperativeMAKE 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.
Receipt of renal replacement treatmentPerioperativePatients received renal replacement therapy after being diagnosed with AKI.
Mortality30 daysMortality at 30 days
length of stay in the ICUPerioperativelength of stay in the ICU
Length of stay in the hospitalPerioperativeLength of stay in the hospital
The number of days of use and cumulative dose of vasoactive drugsPerioperativeThe number of days of use and cumulative dose of vasoactive drugs during ICU stay.
AKI on CKDPerioperativeNumber of patients with CKD develop AKI after surgery

Countries

China

Contacts

CONTACTGuo wei Tu, MD
tu.guowei@zs-hospital.sh.cn86-021-64041990
CONTACTYing Su, MD
su.ying@zs-hospital.sh.cn+86 021 64041990
STUDY_DIRECTORZhe Luo, MD

Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026