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Ear zap may shield kidneys during heart surgery

NCT ID NCT07549243

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 2 times

Summary

This study tests a non-invasive ear stimulation technique (taVNS) to prevent acute kidney injury in 152 adults having heart surgery with a heart-lung machine. Half receive real stimulation before and after surgery; the other half get a sham. The main goal is to see if fewer people develop kidney damage within a week.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 152 people

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

Started

Apr 2026

Expected to finish

May 2027

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.

Ages

18 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: * Age ≥18 years * Scheduled for elective cardiac surgery with cardiopulmonary bypass under general anesthesia * Baseline estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (CKD-EPI formula) * American Society of Anesthesiologists (ASA) physical status classification I-III * New York Heart Association (NYHA) functional classification I-III * Able to understand and cooperate with study procedures * Willing to participate and provide written informed consent. For participants unable to read or sign due to incapacity or illiteracy, consent may be obtained from a legally authorized representative or witnessed by an impartial third party as per ethical guidelines Exclusion Criteria: * Solitary kidney, history of kidney transplantation, pre-existing renal replacement therapy, or pre-existing acute kidney injury (KDIGO criteria) * Contraindications to transcutaneous auricular vagus nerve stimulation, including active infection, dermatitis, skin breakdown, or severe psoriasis in the bilateral auricular region; allergy to silicone, electrode gel, or device materials; uncontrolled arrhythmia, symptomatic bradycardia, sick sinus syndrome, second- or third-degree atrioventricular block, implanted pacemaker or defibrillator; carotid sinus hypersensitivity; uncontrolled epilepsy; or active peptic ulcer disease * Received vagus nerve stimulation, auricular acupuncture, or transcutaneous electrical nerve stimulation within 1 month prior to enrollment * Long-term use of medications that significantly affect autonomic nervous system tone or renal blood flow and cannot be safely paused before surgery * Active systemic infection or sepsis (Sepsis-3 criteria) prior to surgery * Acute ischemic or hemorrhagic stroke, or acute myocardial infarction within 3 months prior to enrollment * Severe hepatic dysfunction (Child-Pugh Class C), acute liver failure, or other serious life-threatening conditions * Vulnerable populations (excluding elderly or illiterate individuals) including critically ill patients, individuals with psychiatric disorders, cognitive impairment, or pregnant women * Any other condition deemed by the investigator to make the participant unsuitable for study participation

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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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

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