180 Fenglin Road
Shanghai, 200032, China
NCT Number: NCT07521787
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Observational
Shanghai, 200032, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The risk factors includes:
Exclusion criteria
The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.
Time frame: 3 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Time frame: 48 hours
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Time frame: 7 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Time frame: 7 days
Severe AKI includes stage 2 and stage 3 AKI based on KDIGO criteria.
Time frame: 365 days
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.
Time frame: 90 days
Patients received renal replacement treatment during hospital stay
Time frame: 365 days
Mortality at 30 days, 90 days and 365 days.
Time frame: Perioperative
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 during ICU stay.
Time frame: Perioperative
Rate of patients with CKD before surgery and develop AKI after surgery
Contact information is provided by the study sponsor or research team.
Guo wei Tu, MD
CONTACT
Ying Su, MD
CONTACT
Shanghai Zhongshan Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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