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A simple sensor on the back could warn of kidney danger during heart surgery

NCT ID NCT07760129

Knowledge-focused Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study tests whether a non-invasive sensor placed on the back can detect early signs of kidney injury in adults undergoing off-pump coronary artery bypass surgery. Kidney injury is common after such surgery, but current detection relies on blood tests that rise days later. The sensor measures oxygen levels in the erector spinae muscle, which lies close to the kidney's blood supply, potentially offering a real-time warning. Researchers will monitor 138 patients during surgery and compare sensor readings with kidney function after the operation.

What this could mean

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

Active substance
Near-infrared spectroscopy monitoring of erector spinae muscle and renal regional oxygen saturation
What this could lead to
If it works, this could enable real-time, non-invasive detection of patients at high risk for kidney injury during heart surgery, allowing earlier intervention and potentially reducing complications.
What could go wrong
This is an observational study, not a treatment trial, so it cannot change outcomes directly. The sensor's accuracy may be limited, and results may not apply to all patients or surgery types.

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

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

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

Consecutive adult patients (19 years of age or older) scheduled for elective off-pump coronary artery bypass surgery at Severance Hospital, a tertiary university hospital in Seoul, Republic of Korea, who provide written informed consent. After consent, ultrasonography performed in the operating room before anesthetic induction measures the depth from the skin to the erector spinae muscle at the level of the left renal hilum; only patients in whom this depth is less than 2.0 cm, so that a reliable near-infrared spectroscopy signal can be obtained, are finally enrolled. Patients requiring emergency or concomitant surgery, those with severe renal impairment (estimated glomerular filtration rate below 30 mL/min/1.73 m2), previous kidney transplantation, left renal disease or a solitary kidney, a body mass index above 30 kg/m2, cardiogenic shock or mechanical circulatory support, or active bleeding or infection are not eligible.

Ages

19 years and older

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.

Inclusion Criteria: 1. Adults aged 19 years or older scheduled for elective off-pump coronary artery bypass (OPCAB) surgery. 2. Able to receive a full explanation of the purpose and procedures of the study and to provide written informed consent voluntarily. 3. Depth from the skin to the erector spinae muscle at the level of the left renal hilum, measured by ultrasonography in the operating room before anesthetic induction, of less than 2.0 cm, so that stable near-infrared spectroscopy measurement is considered feasible. Consenting patients who do not meet this criterion are not enrolled and are classified as screen failures. Exclusion Criteria: 1. Emergency surgery. 2. Concomitant surgery performed by another department. 3. Preoperative or postoperative cardiogenic shock, or need for mechanical circulatory support. 4. Estimated glomerular filtration rate below 30 mL/min/1.73 m2. 5. Previous kidney transplantation. 6. Left renal disease or a solitary kidney. 7. Body mass index above 30 kg/m2. 8. Active bleeding or active infection. 9. Inability to read and voluntarily consent to the informed consent document (for example, because of illiteracy, language barrier, or cognitive impairment). 10. Refusal to participate in the study.

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Conditions

The condition(s) this trial relates to.

acute kidney injury coronary artery disorder Postoperative Complications

As listed by the trial registrant

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

Acute kidney injury Cardiac surgical procedures Coronary artery bypass, off-pump Coronary artery disease Postoperative complications Spectroscopy, near-infrared

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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