Gut bacteria may foretell kidney danger after heart surgery
NCT ID NCT07738796
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This study looks at whether the bacteria in your gut and the substances they produce can help predict a serious complication called acute kidney injury (AKI) after heart surgery. Researchers will collect stool and blood samples from about 180 adults before and after their operation to analyze these gut-related markers. The goal is to build a risk model that could identify high-risk patients early, potentially leading to preventive measures and better recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- No drug or device is being tested. This observational study collects stool and blood samples to analyze gut bacteria and their byproducts.
- What this could lead to
- If successful, this could lead to a simple test that predicts which heart surgery patients are at risk for kidney injury, enabling earlier prevention and better outcomes.
- What could go wrong
- This is an early, observational study, so it cannot prove cause and effect. The model may not be accurate enough for widespread use, and findings may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 182 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
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