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NCT07521787

Prognostic Value of Metabolic Characteristics in High-Risk Populations for Acute Kidney Injury After Cardiac Surgery

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

This project aims to explore the metabolic characteristics of adverse renal outcomes in high-risk populations after cardiac surgery by using multi-omics techniques, in order to understand the metabolic changes in patients during the process of renal function decline and recovery. At the same time, this project will search for combinations of metabolic markers that predict the occurrence of adverse outcomes, establish predictive models, to help clinical early identification and warning of AKI, and implement prevention and intervention strategies, thereby improving the prognosis of patients and enhancing the safety and success rate of cardiac surgery.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

540

Start Date

2026-04-23

Completion Date

2029-12-30

Last Updated

2026-04-13

Healthy Volunteers

Conditions

Cardiac Surgery Associated - Acute Kidney Injury Critical Illness

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.

Inclusion Criteria: * All patients is going to undergo non-emergency cardiac surgeries, including cardiopulmonary bypass or non-cardiopulmonary bypass surgeries; * Patients must have the risk of developing AKI, and at least meet one of the following criteria: cardiopulmonary bypass cardiac surgery + at least one risk factor; or non-cardiopulmonary bypass surgery such as simple coronary artery bypass grafting + at least two AKI risk factors. The risk factors includes: * Age ≥ 70 years; * Diabetes (type 1 or type 2), requiring at least one oral hypoglycemic drug or insulin; * 30 ≤ eGFR ≤ 60 mL/min/1.73 m2 (CKD-EPI formula); * Recorded history of proteinuria (random urine albumin-to-creatinine ratio UACR \> 30 mg/g, or 24-hour urine albumin \> 300 mg/24 hours, or urine protein ≥ +1 in urine test strips/urine routine tests); * Previous history of hospitalization for congestive heart failure or NYHA classification III/IV; * Left ventricular ejection fraction (LVEF) ≤ 40%; ⑦ Previous history of open-chest cardiac surgery; * CABG combined with valve surgery; ⑨ Surgery involving more than one heart valve; ⑩ Emergency surgery; ⑪ Preoperative IABP Exclusion Criteria: * There were urgent indications for initiating RRT at the time of enrollment, including serum potassium ≥ 6.0 mmol/L, pH value ≤ 7.20, serum bicarbonate ≤ 12 mmol/L, oxygenation index ≤ 200 mmHg; presence of volume overload, severe respiratory failure, etc.; * Preoperative end-stage CKD (eGFR \< 30 mL/min/1.73 m2; or RRT treatment had been received within 4 weeks before enrollment); * AKI was present at screening. But transient (≤ 5 days) stage 1 AKI after iodinated contrast agent exposure will be included in this study. * Previous kidney transplantation or urinary tract obstruction and other urinary system diseases; * End-stage heart disease, HIV infection, hematological tumors, etc., * with an expected survival period of \< 1 year; * being in a moribund state (with an anticipated likelihood of death within 48 hours); * Multiple transfers to ICU; * Pregnant or lactating women; * Medical or psychological conditions that the investigator believed might interfere with the subject's participation in the study, or confuse the subject's assessment or study outcome.

Locations (1)

180 Fenglin Road

Shanghai, China