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Prognostic Value of New Biomarker on Adverse Renal Outcomes in High-Risk Cardiac surgery Patients

Prognostic Value of New Biomarker on Adverse Renal Outcomes in High-Risk Cardiac surgery Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123226
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-04-23
Completion date
Unknown
Last updated
2026-04-27

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

Interventions

Case series :none

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient (or their guardian) signs the informed consent form. 2. Age >= 18 years. 3. All patients underwent non-emergency cardiac surgeries, including cardiopulmonary bypass or non-cardiopulmonary bypass surgeries. 4. 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: (1) Age >= 70 years; (2) Diabetes (type 1 or type 2), requiring at least one oral hypoglycemic drug or insulin; (3) 30 = eGFR 30 mg/g, or 24-hour urine albumin > 300 mg/24 hours, or urine protein >= +1 in urine test strips/urine routine tests); (5) Previous history of hospitalization for congestive heart failure or NYHA classification III/IV; (6) Left ventricular ejection fraction (LVEF) <= 40%; (7) Previous history of open-chest cardiac surgery (regardless of whether extracorporeal circulation was used); (8) CABG combined with valve surgery; (9) Surgery involving more than one heart valve; (10) Emergency surgery; (11) Preoperative IABP.

Exclusion criteria

Exclusion criteria: 1. 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. 2. Preoperative end-stage CKD (eGFR < 30 mL/min/1.73 m^2; or RRT treatment had been received within 4 weeks before enrollment); 3. AKI was present at screening. But transient (<= 5 days) stage 1 AKI after iodinated contrast agent exposure will be included in this study. 4. Previous kidney transplantation or urinary tract obstruction and other urinary system diseases; 5. End-stage heart disease, HIV infection, hematological tumors, etc., with an expected survival period of < 1 year; 6. Expected survival time < 48 hours or patients with a DNR order; 7. Multiple transfers to ICU; 8. Pregnant or lactating women; 9. 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.

Design outcomes

Primary

MeasureTime frame
AKI occurrence within 3 days;

Secondary

MeasureTime frame
AKI occurrence within 7 days;MAKE at discharge, 30days, 90 days, and 365 days;Severe AKI occurrence within 7 days;AKI occurrence within 48 hours;Receipt of renal replacement treatment during hospital stay;mortality within 30 days?90 days and 365 days;Length of stay in the ICU;Length of stay in the hospital;Patients with CKD before surgery develop AKI after surgery;The number of days of use and cumulative dose of vasoactive drugs during ICU stay;

Countries

China

Contacts

Public ContactYing Su

Zhongshan Hospital, Fudan University

su.ying@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026