NCT07521787

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 540 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cardiac Surgery Associated - Acute Kidney Injury
• Critical Illness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-23
• Primary completion: 2029-12-30
• Completion: 2029-12-30
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China