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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

28 juillet 2026 mis à jour par: Peking Union Medical College Hospital
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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

Cardiac surgery-associated acute kidney injury (CSA-AKI) is one of the most common severe postoperative complications after cardiac surgery, which significantly increases the risks of prolonged hospitalization, chronic kidney disease and all-cause mortality. Current single-index risk scoring systems cannot fully predict individual CSA-AKI risk, and the underlying pathological mechanism remains incompletely clarified. Emerging evidence reveals that gut dysbiosis and altered intestinal metabolites participate in kidney injury via the gut-kidney axis, while few prospective cohort studies integrate multi-omics data to develop preoperative predictive models for CSA-AKI.

This prospective cohort study will consecutively recruit adult subjects receiving elective cardiac surgery at Peking Union Medical College Hospital. Basic demographic data, laboratory examinations, intraoperative and postoperative clinical parameters will be recorded at multiple perioperative time points. Fresh stool specimens and artery blood will be collected from all participants before surgery, 24 hours and 7 days after cardiac surgery for 16S rRNA gene sequencing and untargeted metabolomics analysis to characterize gut microbial composition and metabolite profiles.

The primary objective is to develop and internally validate a multi-dimensional predictive model combining clinical variables, gut flora biomarkers and metabolic signatures to stratify preoperative CSA-AKI risk of cardiac surgical patients. Secondary objectives include comparing the differences of intestinal microbiota and metabolites between patients with and without subsequent CSA-AKI, screening key microbial strains and differential metabolites related to postoperative renal impairment, and elucidate the molecular pathways of the gut-kidney axis mediating CSA-AKI occurrence.

All participants will receive standardized perioperative management following clinical guidelines. Subjects will be followed up until 7 days after surgery to identify CSA-AKI events defined by standardized serum creatinine criteria. The performance of the established prediction model will be evaluated by area under the receiver operating characteristic curve (AUC), calibration curve and decision curve analysis. All specimen testing and statistical analyses will be conducted following standardized omics and clinical research workflows. This study is approved by the institutional ethics committee, and written informed consent will be obtained from all enrolled patients prior to sample and data collection.

Type d'étude

Observationnel

Inscription (Estimé)

182

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100730
        • Peking Union Medical College Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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:

（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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Predictive performance of multi-dimensional gut microbiota-metabolite model for postoperative CSA-AKI
Délai: From preoperative sample collection to postoperative day 7 (CSA-AKI confirmation)
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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) within 7 days after cardiac surgery
Délai: 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.
7 days after cardiac surgery
Severity grading of CSA-AKI according to KDIGO 2012 staging criteria
Délai: 7 days after cardiac surgery
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.
7 days after cardiac surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking Union Medical College Hospital

Les enquêteurs

  • Chercheur principal: Yu, Peking Union Medical College Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

28 juillet 2026

Première soumission répondant aux critères de contrôle qualité

28 juillet 2026

Première publication (Réel)

31 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • K10744

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data (including perioperative clinical laboratory data, gut microbiota sequencing raw data, stool metabolomics and blood data, and standardized case report forms) will be shared with qualified researchers after the completion of primary study analysis and the publication of core research manuscripts. All personal identifiable information will be permanently removed to protect patient privacy in compliance with Chinese medical research ethics regulations.

Critères d'accès au partage IPD

Data will become available 6 months after full study completion and primary manuscript publication; data access will remain available for 5 years after publication.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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