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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Age ≥ 70 years;

Diabetes (type 1 or type 2), requiring at least one oral hypoglycemic drug or insulin;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard care "bundle"

    Other intervention

    The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: Model development cohort1 intervention
Group B: Model validation cohort1 intervention

Trial outcomes

Primary outcomes

1

Rate of AKI occurrence within 3 days

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

Time frame
3 days

Secondary outcomes

1

Rate of AKI within 48 hours

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

Time frame
48 hours
2

Rate of AKI within 7 days

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

Time frame
7 days
3

Rate of Severe AKI occurrence within 7 days

Severe AKI includes stage 2 and stage 3 AKI based on KDIGO criteria.

Time frame
7 days
4

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.

Time frame
365 days

Other outcomes

Sponsors and contacts

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