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

NCT07521787 | Not Yet Recruiting DMC

• 1 other identifier: B2025-849
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery Associated - Acute Kidney Injury; Critical Illness

Keywords

Acute kidney injury; Biomarker; Metabolic characteristics; Poor outcome; Prognostic value; Cardiac surgery associated AKI

Outcome Measures

Primary Outcomes (1)

• Rate of AKI occurrence within 3 days

  AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

  3 days

Secondary Outcomes (10)

• Rate of AKI within 48 hours

  48 hours

• Rate of AKI within 7 days

  7 days

• Rate of Severe AKI occurrence within 7 days

  7 days

• Rate of major adverse kidney events

  365 days

• Rate of receipt of renal replacement treatment

  90 days

Study Arms (2)

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.

Other: Standard care "bundle"

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.

Other: Standard care "bundle"

Interventions

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.

Model development cohort; Model validation cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• All patients is going to undergo non-emergency cardiac surgeries, including cardiopulmonary bypass or non-cardiopulmonary bypass surgeries;
• 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:
• Age ≥ 70 years;
• Diabetes (type 1 or type 2), requiring at least one oral hypoglycemic drug or insulin;
• ≤ 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;
• CABG combined with valve surgery; ⑨ Surgery involving more than one heart valve; ⑩ Emergency surgery; ⑪ Preoperative IABP

You may not qualify if:

• 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.;
• Preoperative end-stage CKD (eGFR \< 30 mL/min/1.73 m2; or RRT treatment had been received within 4 weeks before enrollment);
• AKI was present at screening. But transient (≤ 5 days) stage 1 AKI after iodinated contrast agent exposure will be included in this study.
• Previous kidney transplantation or urinary tract obstruction and other urinary system diseases;
• End-stage heart disease, HIV infection, hematological tumors, etc.,
• with an expected survival period of \< 1 year;
• being in a moribund state (with an anticipated likelihood of death within 48 hours);
• Multiple transfers to ICU;
• Pregnant or lactating women;
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Zhe Luo, Professor

  Zhongshan hospital, Fudan university,Shanghai, China

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Secretary for Cardiac Intensive Care Center

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): April 23, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2025-12

Locations

CN (1)