Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard care "bundle".
- Who it may be relevant to
- Registry conditions: Cardiac Surgery Associated - Acute Kidney Injury, Critical Illness. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
Overview
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
- 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.
Primary outcome measures
- AKI occurrence within 7 days [Time frame: 7 days]
Secondary outcome measures (10)
- Moderate and severe AKI occurrence within 7 days [Time frame: 7 days]
- AKI occurrence within 48 hours [Time frame: 48 hours]
- AKI occurrence within 3 days [Time frame: 3 days]
- Major adverse kidney events [Time frame: Perioperative]
- Receipt of renal replacement treatment [Time frame: Perioperative]
- Mortality [Time frame: 30 days]
- length of stay in the ICU [Time frame: Perioperative]
- Length of stay in the hospital [Time frame: Perioperative]
- The number of days of use and cumulative dose of vasoactive drugs [Time frame: Perioperative]
- AKI on CKD [Time frame: Perioperative]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Zhongshan hospital, Fudan university — Shanghai
- Zhongshan hospital — Shanghai
Identifiers
NCT: NCT07418242 · B2025-549