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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.
This project is a prospective observational study. It is proposed to be divided into a model development cohort and a model validation cohort. In the model development cohort, it is planned to select patients from the sample bank at high risk of AKI who underwent cardiac surgery. Pick those patients who developed AKI and who did not develop AKI for 1:1 matching, with 30 cases in each group. Blood and urine samples of the patients before the operation and 6-12 hours after cardiac surgery were collected. The non-target metabolome, proteome and transcriptome of the blood and urine samples will be detected. Through a multi-omics combined analysis strategy, significantly different metabolic pathways and metabolic molecule combinations were screened. The occurrence of postoperative AKI was taken as the main endpoint of the study. Through methods such as logistic regression, the combinations of medical history, laboratory data and specimen test results and multi-omics factors that can be used to predict and warn of the main research endpoints at an early stage were preliminarily screened. A predictive model will be established and its non-inferiority over traditional markers will be tested. At the same time, the validation cohort will be established: all high-risk populations who underwent cardiac surgery will be prospectively included. Blood and urine samples will be collected before and within 24 hours after the operation. The target metabolites will be detected in blood and urine samples by ELISA or mass spectrometry, and correlation analysis will be conducted with the research endpoint to verify the stability and reliability of the model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model development cohort | The model development cohort is planned to select patients from the sample bank at high risk of AKI who underwent cardiac surgery. Pick those patients who developed AKI and who did not develop AKI for 1:1 matching, with 30 cases in each group. Through methods such as logistic regression, the combinations of medical history, laboratory data and specimen test results and multi-omics factors that can be used to predict and warn of the main research endpoints at an early stage were preliminarily screened.A predictive model will be established and its non-inferiority over traditional markers will be tested. |
| |
| Model validation cohort | The validation cohort will be established: all high-risk populations who underwent cardiac surgery from 2026-1 to 2029-12 will be prospectively included. Blood and urine samples will be collected before and within 24 hours after the operation. The target metabolites will be detected in blood and urine samples by ELISA or mass spectrometry, and correlation analysis will be conducted with the research endpoint to verify the stability and reliability of the model. |
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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 |
|---|---|---|
| Rate of AKI occurrence within 3 days | AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of AKI within 48 hours | AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria. | 48 hours |
| Rate of AKI within 7 days | AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria. |
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Inclusion Criteria:
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;
Exclusion Criteria:
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The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. 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. Patients was diagnosed AKI by KDIGO criteria.
| 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, Professor | Zhongshan hospital, Fudan university,Shanghai, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | 200032 | 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 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.
| 7 days |
| Rate of Severe AKI occurrence within 7 days | Severe AKI includes stage 2 and stage 3 AKI based on KDIGO criteria. | 7 days |
| Rate of major adverse kidney events | Collect MAKE at discharge, 30days, 90 days, and 365 days after surgery. 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. | 365 days |
| Rate of receipt of renal replacement treatment | Patients received renal replacement treatment during hospital stay | 90 days |
| Mortality | Mortality at 30 days, 90 days and 365 days. | 365 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 |
| Rate of patients with CKD before surgery and develop AKI after surgery | Rate of patients with CKD before surgery and develop AKI after surgery | Perioperative |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |