Development and Validation of a Risk Prediction Model for Cardiac Surgery-associated Acute Kidney Injury Based on the Gut-Kidney Axis, Incorporating Gut Microbiota and Their Metabolites

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

This is a single-center prospective observational cohort study enrolling adult patients scheduled for cardiac surgery. Multi-timepoint clinical indicators, stool samples for gut microbiota and metabolomics profiling and artery blood will be collected before and after surgery. We aim to construct and validate a multi-dimensional preoperative predictive model for CSA-AKI based on clinical, microbial and metabolic signatures. Meanwhile, this research will explore the potential mediating role of the gut-kidney axis in the pathogenesis of cardiac surgery-associated acute kidney injury, and provide novel mechanistic evidence for early risk stratification and intervention of CSA-AKI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older;

Scheduled for elective cardiac surgery;

Surgery performed under cardiopulmonary bypass (CPB);

Able to complete preoperative stool and blood sample collection independently;

Disqualifiers

None

Trial population

This single-center prospective observational cohort will consecutively enroll adult patients aged ≥18 years who receive elective cardiac surgery at Peking Union Medical College Hospital. Eligible subjects include patients undergoing valve surgery, coronary artery bypass grafting (CABG), or combined cardiac procedures.All enrolled participants will complete standardized perioperative data collection and serial stool sample and blood collection at preoperative baseline, postoperative day 1 and postoperative day 7. Subjects will be followed up until postoperative day 7 to identify CSA-AKI events based on KDIGO 2012 criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

182 Participants
are grouped into 1 trial group
Group A: all patients undergoing elective cardiac surgery

Trial outcomes

Primary outcomes

1

Predictive performance of multi-dimensional gut microbiota-metabolite model for postoperative CSA-AKI

The primary outcome is the discriminative ability (AUC) of the combined preoperative gut microbiota and metabolomic signature model to predict cardiac surgery-associated acute kidney injury (CSA-AKI). CSA-AKI is diagnosed per KDIGO 2012 criteria: serum creatinine rises ≥0.3 mg/dL within 48h postoperatively or ≥1.5-fold baseline within 7 days after cardiac surgery. The predictive performance of the multi-omics combined model will be quantified by the area under the receiver operating characteristic curve (AUC-ROC).

Time frame
From preoperative sample collection to postoperative day 7 (CSA-AKI confirmation)

Secondary outcomes

1

Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) within 7 days after cardiac surgery

CSA-AKI is diagnosed in accordance with the KDIGO 2012 AKI standard: serum creatinine increases by ≥0.3 mg/dL within 48 hours postoperatively, or serum creatinine reaches ≥1.5 times the preoperative baseline value within 7 days after cardiac surgery. The incidence rate is calculated as the proportion of patients who meet the CSA-AKI diagnostic criteria among all enrolled subjects.

Time frame
7 days after cardiac surgery
2

Severity grading of CSA-AKI according to KDIGO 2012 staging criteria

For subjects diagnosed with CSA-AKI within postoperative 7 days, stratify patients into KDIGO Stage 1, Stage 2 and Stage 3 based on the maximum serum creatinine elevation during follow-up, and compare the distribution of AKI severity grades in the cohort.

Time frame
7 days after cardiac surgery

Other outcomes

Sponsors and contacts

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