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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care "bundle" | Other | The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline. |
| Measure | Description | Time Frame |
|---|---|---|
| AKI occurrence within 7 days | AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate and severe AKI occurrence within 7 days | Stage 2 and stage 3 AKI based on KDIGO criteria. | 7 days |
| AKI occurrence within 48 hours | AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria. |
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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:
Exclusion criteria:
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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%.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo wei Tu, MD | Contact | 86-021-64041990 | tu.guowei@zs-hospital.sh.cn | |
| Ying Su, MD | Contact | +86 021 64041990 | su.ying@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhe Luo, MD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital, Fudan university | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
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2-5ml blood and urine samples for biomarker analysis will be collected before surgery and within 6-12 hours after surgery. Plasma (EDTA), serum, and urine supernatants were frozen within 2 h of sample collection, stored at -80#, and thawed immediately before analysis.
| 48 hours |
| AKI occurrence within 3 days | AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria. | 3 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 |
| Mortality | Mortality at 30 days | 30 days |
| 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 |
| Zhongshan hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |