New study aims to predict kidney damage after heart surgery using metabolic clues
NCT ID NCT07521787
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how certain metabolic changes in the body might help predict kidney injury after heart surgery. Researchers will study 540 high-risk patients to find patterns that could warn doctors early. The goal is to improve patient safety and outcomes by catching kidney problems sooner.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 540 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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
The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. Patients was diagnosed AKI by KDIGO criteria.
- Ages
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18 to 90 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: * All patients is going to undergo non-emergency cardiac surgeries, including cardiopulmonary bypass or non-cardiopulmonary bypass surgeries; * Patients must have the risk of developing AKI, and at least meet one of the following criteria: cardiopulmonary bypass cardiac surgery + at least one risk factor; or non-cardiopulmonary bypass surgery such as simple coronary artery bypass grafting + at least two AKI risk factors. The risk factors includes: * Age ≥ 70 years; * Diabetes (type 1 or type 2), requiring at least one oral hypoglycemic drug or insulin; * 30 ≤ eGFR ≤ 60 mL/min/1.73 m2 (CKD-EPI formula); * Recorded history of proteinuria (random urine albumin-to-creatinine ratio UACR \> 30 mg/g, or 24-hour urine albumin \> 300 mg/24 hours, or urine protein ≥ +1 in urine test strips/urine routine tests); * Previous history of hospitalization for congestive heart failure or NYHA classification III/IV; * Left ventricular ejection fraction (LVEF) ≤ 40%; ⑦ Previous history of open-chest cardiac surgery; * CABG combined with valve surgery; ⑨ Surgery involving more than one heart valve; ⑩ Emergency surgery; ⑪ Preoperative IABP Exclusion Criteria: * There were urgent indications for initiating RRT at the time of enrollment, including serum potassium ≥ 6.0 mmol/L, pH value ≤ 7.20, serum bicarbonate ≤ 12 mmol/L, oxygenation index ≤ 200 mmHg; presence of volume overload, severe respiratory failure, etc.; * Preoperative end-stage CKD (eGFR \< 30 mL/min/1.73 m2; or RRT treatment had been received within 4 weeks before enrollment); * AKI was present at screening. But transient (≤ 5 days) stage 1 AKI after iodinated contrast agent exposure will be included in this study. * Previous kidney transplantation or urinary tract obstruction and other urinary system diseases; * End-stage heart disease, HIV infection, hematological tumors, etc., * with an expected survival period of \< 1 year; * being in a moribund state (with an anticipated likelihood of death within 48 hours); * Multiple transfers to ICU; * Pregnant or lactating women; * Medical or psychological conditions that the investigator believed might interfere with the subject's participation in the study, or confuse the subject's assessment or study outcome.
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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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180 Fenglin Road
Shanghai, 200032, China
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