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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129101
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac surgery-associated acute kidney injury

Interventions

CSA-AKI group & non-CSA-AKI group:None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older; 2. Scheduled for elective cardiac surgery; 3. Surgery performed under cardiopulmonary bypass (CPB); 4. Able to complete preoperative stool and blood sample collection independently; 5. 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.

Exclusion criteria

Exclusion criteria: 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/1.73m^2 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).

Design outcomes

Primary

MeasureTime frame
Predictive efficacy of microbiota-metabolites for CSA-AKI;

Secondary

MeasureTime frame
Incidence of acute kidney injury (AKI) within 7 days after cardiac surgery;AKI severity;Persistent AKI (>=48 hours);Total postoperative hospital stay,ICU stay duration;In-hospital mortality;90-day postoperative mortality;

Countries

China

Contacts

Public ContactChunhua Yu

Peking Union Medical College Hospital

yuchh@pumch.cn+86 13811585975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026