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

NCT07738796 | Not Yet Recruiting DMC

• 1 other identifier: K10744
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury After Adult Cardiac Surgery; Gastrointestinal Microbiome; Metabolome; Risk Assessment

Keywords

cardiac surgery-associated acute kidney injury; gut microbiota; metabolites; gut-kidney axis; preoperative predictive model

Outcome Measures

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).

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

Secondary Outcomes (2)

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

  7 days after cardiac surgery

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

  7 days after cardiac surgery

Study Arms (1)

all patients undergoing elective cardiac surgery

Consecutive adult patients scheduled for cardiac surgery. Multi-timepoint clinical data and stool samples are collected to build preoperative CSA-AKI prediction model, subgroup analysis will be performed according to postoperative AKI outcomes.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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;
• The patient and their family members voluntarily participate in this study, agree to the collection of preoperative stool samples, blood samples and clinical data, cooperate with follow-up visits, and sign the informed consent form.-

You may not qualify if:

• （1) Patients with end-stage renal disease or dependence on renal replacement therapy before surgery; (2) Patients with a preoperative estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² or severe chronic kidney disease (CKD stage 4-5); (3) Patients with a history of renal transplantation or unilateral nephrectomy; (4) Patients who received antibiotic treatment within 4 weeks before surgery; (5) Patients who took probiotic or prebiotic preparations within 4 weeks before surgery; (6) Patients with a previous history of intestinal surgery, such as colectomy and small bowel resection; (7) Patients with active inflammatory bowel disease, chronic diarrhea or constipation requiring pharmacological intervention; (8) Patients with preoperative intestinal obstruction, gastrointestinal bleeding, or those requiring fasting for more than 24 hours; (9) Patients undergoing emergency surgery (time from admission to surgery \< 24 hours), or those unable to complete preoperative informed consent, dietary investigation and baseline sample collection; (10) Patients who received mechanical bowel preparation (e.g., enema) within 24 hours before surgery; (11) Patients with preoperative active infection or sepsis; (12) Patients treated with preoperative glucocorticoids or immunosuppressants (excluding routine doses); (13) Patients who died intraoperatively or within 24 hours postoperatively, or those who could not complete the evaluation of the primary outcome (postoperative 7-day acute kidney injury \[AKI\]); (14) Female patients who are pregnant, lactating or in menstruation; (15) Patients complicated with gastrointestinal malignant tumors or receiving systemic chemotherapy, targeted therapy or abdominal radiotherapy; (16) Patients with severe liver disease (Child-Pugh grade B or above).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

stools, artery blood

Study Officials

• Yu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunhua Yu, MD

CONTACT

+86 13811585975; yu.chunhua@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Data will become available 6 months after full study completion and primary manuscript publication; data access will remain available for 5 years after publication.

Locations

CN (1)