Development and Validation of a Risk Prediction Model for Cardiac Surgery-associated Acute Kidney… (NCT07738796) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
China182 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on building a prediction model using gut bacteria and their byproducts to identify who might develop kidney injury after heart surgery — could my gut microbiome profile or any of my metabolite levels give you useful information about my personal risk before surgery?
2Since this study isn't recruiting yet and is in a non-interventional, model-development phase, does that mean there's no direct treatment being tested, and would participating mainly involve providing samples like stool or blood for research purposes?
3Given that this research is studying the connection between the gut and the kidneys after cardiac surgery, are there any existing markers or signs in my current health profile that already suggest I might be at higher or lower risk for acute kidney injury after my procedure?
4While this prediction model is still being developed and validated, are there established pre-surgical steps — like optimizing kidney function or gut health — that my care team already uses to reduce the risk of cardiac surgery-associated acute kidney injury?
5If this trial isn't yet open for enrollment, is there a similar or complementary study that is currently recruiting, or would my doctor recommend I focus on standard risk-reduction strategies while this research matures?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive performance of multi-dimensional gut microbiota-metabolite model for postoperative CSA-AKI
Timeframe: From preoperative sample collection to postoperative day 7 (CSA-AKI confirmation)