Cardiac Surgery Associated - Acute Kidney InjuryNCT07521787
Prognostic Value of Metabolic Characteristics in High-Risk Populations for Acute Kidney Injury After Cardiac Surgery
An observational study of Cardiac Surgery Associated - Acute Kidney Injury and Critical Illness, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery Associated - Acute Kidney Injury, Critical Illness
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2026to 30 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
- 30 ≤ eGFR ≤ 60 mL/min/1.73 m2 (CKD-EPI formula);
Show all 10Show fewer
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Standard care "bundle"
- Keywords
- Acute kidney injury, Biomarker, Metabolic characteristics, Poor outcome, Prognostic value, Cardiac surgery associated AKI
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care "bundle" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of AKI occurrence within 3 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 3 days
Secondary outcomes (10)
Rate of AKI within 48 hours
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 48 hours
Rate of AKI within 7 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 7 days
Rate of Severe AKI occurrence within 7 days
Severe AKI includes stage 2 and stage 3 AKI based on KDIGO criteria.
Measured: 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.
Measured: 365 days
Rate of receipt of renal replacement treatment
Patients received renal replacement treatment during hospital stay
Measured: 90 days
Mortality
Mortality at 30 days, 90 days and 365 days.
Measured: 365 days
length of stay in the ICU
Length of stay in the ICU
Measured: Perioperative
Length of stay in the hospital
Length of stay in the hospital
Measured: 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.
Measured: 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
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start23 Apr 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Associated - Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guowei Tu, Shanghai Zhongshan Hospital
- Investigators
- Zhe Luo, Professor, Study director, Zhongshan hospital, Fudan university,Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521787
- Sponsor's protocol ID
- B2025-849
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided