[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649751":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":22,"responsibleParty":37,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":10,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"all patients undergoing elective cardiac surgery",null,"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.",[13],{"name":14,"affiliation":5,"role":15},"Yu","PRINCIPAL_INVESTIGATOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Chunhua Yu, MD","CONTACT","+86 13811585975","yu.chunhua@aliyun.com",[23],{"facility":5,"status":10,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Beijing","Beijing Municipality","100730","China","CN",{"type":30,"coordinates":31},"Point",[32,33],116.39723,39.9075,{"lat":33,"lon":32},[36],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},{"type":38,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649751","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-100649751",false,"NCT07738796","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","Inclusion Criteria:\n\n1. Aged 18 years or older;\n2. Scheduled for elective cardiac surgery;\n3. Surgery performed under cardiopulmonary bypass (CPB);\n4. Able to complete preoperative stool and blood sample collection independently;\n5. 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.-\n\nExclusion Criteria:\n\n（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) \\\u003C 30 ml\u002Fmin\u002F1.73m² 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 \\\u003C 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).","ALL","18 Years","80 Years",{"count":49,"type":50},182,"ESTIMATED","OBSERVATIONAL","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.",[54,55,56,57],"Acute Kidney Injury After Adult Cardiac Surgery","Gastrointestinal Microbiome","Metabolome","Risk Assessment",[59,60,61,62,63],"cardiac surgery-associated acute kidney injury","gut microbiota","metabolites","gut-kidney axis","preoperative predictive model","NOT_YET_RECRUITING","2026-07-28",{"date":67,"type":68},"2026-07-31","ACTUAL",{"date":70,"type":50},"2026-08-01",{"date":72,"type":50},"2027-08-01",{"name":5,"class":6},1]