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New test may spot kidney trouble early after heart surgery

NCT ID NCT07418242

Knowledge-focused Sponsor: Guowei Tu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study is looking for new markers in blood and urine that could predict kidney injury after heart surgery in high-risk patients. Researchers will follow about 1,500 adults undergoing open-heart surgery and check for kidney problems within a week. The goal is to find better ways to identify who is at risk, so doctors can act sooner.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify patients at high risk for kidney injury after heart surgery earlier, potentially leading to better preventive care.
What could go wrong
This is an observational study, not testing a new treatment. The biomarkers may not prove accurate enough to change clinical practice, and results 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

319 people

The number who actually took part.

Started

Feb 2026

Finished

Aug 2026

Lead sponsor

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

All high-risk AKI patients who underwent cardiac surgery at Zhongshan Hospital Affiliated to Fudan University.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. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Adult patients were included in the study if they were scheduled for elective open chest cavity cardiac surgeries, with or without the use of cardiopulmonary bypass (CPB). Inclusion criteria required that patients undergoing surgery with CPB must have at least one AKI risk factor, whereas those undergoing surgery without CPB needed to have at least two AKI risk factors. The AKI risk factors were as follows: * age \>70 years; * 30 \< estimated glomerular filtration rate (eGFR) \<60 mL·min-1·1.73 m-2; * diabetes mellitus, proteinuria; * a history of congestive heart failure within the previous year; * a left ventricular ejection fraction of 40% or lower; * prior cardiac surgery; * combined coronary artery bypass/valve procedure; * urgent procedure; * preoperative intra-aortic balloon pump. Exclusion criteria: * pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2); * previous RRT before cardiac surgery; * present AKI at screening; * a history of kidney transplant or other kidney diseases; * known pregnancy; * multiple operation during the hospital stay; * being in a moribund state (with an anticipated likelihood of death within 48 hours).

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Conditions

The condition(s) this trial relates to.

acute kidney injury Critical Illness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgery associated - acute kidney injury Critical illness

Contacts and locations

Locations

  • Zhongshan hospital

    Shanghai, Shanghai Municipality, 200032, China

  • Zhongshan hospital, Fudan university

    Shanghai, Shanghai Municipality, 200030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.