Ear zap may shield kidneys during heart surgery
NCT ID NCT07549243
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 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: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute kidney injury are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310016, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Common Anti-Nausea drugs under scrutiny for kidney risk during chemo
- Heart attack delay may signal kidney risk after angioplasty
- ICU kidney injury: does the pattern predict lasting damage?
- Blood filter attached to Heart-Lung machine aims to stop ticagrelor bleeding
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?
- Two blood tests may separate real kidney harm from a false alarm