Acute Kidney InjuryNCT07549243
Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Acute Kidney Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Acute Kidney Injury and Cardiac Surgery, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a common complication after cardiac surgery using cardiopulmonary bypass, leading to longer hospital stays and worse outcomes. Effective preventive therapies are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Nuan Li, 86+13656508509, 22518555@zju.edu.cn
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Acute Kidney Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Randomized Controlled Trial
Acute kidney injury (AKI) is a common complication after cardiac surgery using cardiopulmonary bypass, leading to longer hospital stays and worse outcomes. Effective preventive therapies are lacking.
This randomized controlled trial investigates whether transcutaneous auricular vagus nerve stimulation (taVNS)-a non-invasive ear stimulation technique-can reduce AKI after cardiac surgery. A total of 152 patients undergoing elective cardiac surgery with cardiopulmonary bypass will be randomly assigned to receive either taVNS or sham stimulation. The intervention begins before surgery and continues daily through postoperative day 5.
Read more
The primary outcome is the incidence of AKI within 7 days after surgery. Secondary outcomes include AKI severity, need for dialysis, kidney function recovery, complications, and inflammatory biomarkers.
This study is approved by the institutional ethics committee. All participants will provide written informed consent.
- Conditions
- Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Sham Stimulation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Participants in this arm receive active transcutaneous auricular vagus nerve stimulation (ta-VNS) using the tVNS501 device. Stimulation is delivered to the left cymba conchae (auricular branch of the vagus nerve) with the following parameters: frequency 25 Hz, pulse width 250 µs, 30 seconds on / 30 seconds off cycling. Intensity is adjusted starting from 0.4 V and increased in 0.4 V increments until the participant perceives mild discomfort, then reduced to the highest tolerable non-painful level. The intervention begins on the day of surgery (from the preoperative holding area through 6 hours postoperatively in the ICU) and continues on postoperative days 1 through 5 with two 120-minute sessions per day (at 9:00 and 14:00). The device is applied by trained non-blinded operators.
Sham StimulationDevice
Participants in this arm receive sham stimulation using the same tVNS501 device. Electrodes are placed on the left cymba conchae following the same procedure as the active group, but no electrical current is delivered. The stimulation settings are displayed on the device to maintain blinding, but the output is turned off. The schedule and duration of device application are identical to those in the active stimulation group.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental | Not described Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham Stimulation | Sham comparator | Not described Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Kidney Injury (AKI) Within 7 Days After Surgery
Measured: Within 7 days after surgery
Secondary outcomes (33)
Severity of Acute Kidney Injury (AKI) by KDIGO Stage
The severity of AKI will be assessed using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Patients are staged from Stage 1 to Stage 3 based on the maximal change in serum creatinine from baseline or the duration and intensity of oliguria (reduced urine output). Stage 1 is defined as a 1.5-1.9 fold increase in baseline creatinine; Stage 2 as a 2.0-2.9 fold increase; and Stage 3 as a ≥ 3.0 fold increase, a creatinine level ≥ 4.0 mg/dL, or the initiation of renal replacement therapy. Higher stages represent greater severity of kidney dysfunction and are associated with worse clinical outcomes.
Measured: Within 7 days after surgery
Requirement of Renal Replacement Therapy (RRT)
Proportion of participants requiring acute RRT during index hospitalization.
Measured: From surgery to hospital discharge, assessed daily, up to 90 days
Duration of RRT
Number of days of RRT received during index hospitalization (calculated only for participants who required RRT).
Measured: From initiation to discontinuation of RRT, assessed daily, up to 90 days
Persistent AKI at Postoperative Day 7
Percentage of participants who developed AKI within the first 7 postoperative days and still meet KDIGO criteria for AKI on postoperative day 7.
Measured: Postoperative day 7
Time to Kidney Function Recovery Among Participants With AKI
Number of days from AKI diagnosis to the first day when serum creatinine returns to <1.5 times baseline and no renal replacement therapy is required. Measurement tool: serum creatinine (μmol/L) per KDIGO criteria. Unit of measure: days. Participants who do not recover within 30 days will be censored.
Measured: From AKI diagnosis to recovery, assessed daily, up to 30 days after surgery
Serum Creatinine Level at 30 Days After Surgery
Serum creatinine concentration measured at 30 days after surgery. Measurement tool: serum creatinine assay (enzymatic or Jaffe method) from venous blood sample. Unit of measure: μmol/L.
Measured: At postoperative day 30
Estimated Glomerular Filtration Rate (eGFR) at 30 Days Post-Surgery
eGFR calculated using the CKD-EPI equation based on serum creatinine, age, sex, and race. Measurement tool: CKD-EPI formula applied to serum creatinine value. Unit of measure: mL/min/1.73 m².
Measured: At postoperative day 30
Duration of Mechanical Ventilation
Time from surgical procedure completion to first successful extubation. Unit of measure: hours (or days, if >24 hours). Measurement tool: clinical documentation of intubation and extubation times.
Measured: From the end of surgery until the time of first successful extubation, assessed up to 30 days.
Vasoactive-Inotropic Score (VIS) - Peak and Mean Values
Peak (maximum) and mean vasoactive-inotropic score calculated daily using standard formula (dopamine, dobutamine, epinephrine, norepinephrine, vasopressin, milrinone). Unit of measure: score (unitless). Measurement tool: documented medication doses and calculation formula per institutional protocol.
Measured: Within the first 7 postoperative days, assessed daily
Incidence of Postoperative Delirium Within 7 Days After Surgery
Proportion of participants who develop delirium as assessed by the Confusion Assessment Method (CAM) for non-ICU patients or CAM-ICU for ICU patients. Unit of measure: percentage of participants. Measurement tool: CAM or CAM-ICU. Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). These tools evaluate four clinical features: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. A diagnosis of delirium is positive if features 1 and 2 are present, along with either feature 3 or 4. This is a binary outcome (Yes/No); no numerical scale score will be reported. Therefore, the outcome is reported as the proportion of participants who meet the diagnostic criteria.
Measured: Daily from postoperative day 1 through day 7
Change in Mini-Mental State Examination (MMSE) Score From Baseline
MMSE total score (range 0-30, higher scores indicate better cognitive function) assessed at three time points. Unit of measure: score points. Measurement tool: Mini-Mental State Examination.
Measured: Preoperative day 1, postoperative day 3, and postoperative day 7
Sleep Quality Assessed by Richards-Campbell Sleep Questionnaire (RCSQ)
RCSQ total score (range 0-100, higher scores indicate better sleep quality). Unit of measure: score points. Measurement tool: Richards-Campbell Sleep Questionnaire.
Measured: Preoperative day 1 (baseline), postoperative day 1 morning (assessing night of surgery), and postoperative day 3 morning (assessing night of day 2)
Quality of Recovery Measured by QoR-15 Questionnaire
QoR-15 total score (range 0-150, higher scores indicate better recovery). Unit of measure: score points. Measurement tool: 15-item Quality of Recovery questionnaire.
Measured: Preoperative day 1, postoperative day 1, postoperative day 3, and postoperative day 7
Postoperative Pain Intensity Measured by Numeric Rating Scale (NRS)
NRS pain score (range 0-10, 0=no pain, 10=worst possible pain). Peak and mean values may be reported. Unit of measure: score points. Measurement tool: Numeric Rating Scale.
Measured: Within the first 48 postoperative hours (assessed at least daily)
Total Postoperative Opioid Consumption
Cumulative opioid dose converted to oral morphine equivalents (milligrams). Unit of measure: milligrams of oral morphine equivalents. Measurement tool: medication administration records and standard conversion table.
Measured: Within the first 48 postoperative hours
Heart Rate Variability (HRV) Parameters
Measured: Preoperative, 24 hours, 48 hours, and 72 hours post-surgery
Incidence of Perioperative Complications
Measured: Within 30 days after surgery
Hospital Length of Stay
Total number of days from the date of surgery to the date of hospital discharge. Unit of measure: days. Measurement tool: hospital medical records.
Measured: From surgery admission to hospital discharge, assessed daily, up to 90 days
Intensive Care Unit (ICU) Length of Stay
Total number of days from ICU admission following surgery to ICU discharge. Unit of measure: days. Measurement tool: ICU medical records.
Measured: From ICU admission after surgery to ICU discharge, assessed daily, up to 30 days
Readmission Rate
Measured: Within 30 days after discharge
Postoperative Serum C-reactive Protein (CRP) Levels
Serum concentration of C-reactive protein (CRP) measured to monitor systemic inflammatory response after cardiac surgery.
Unit of Measure: mg/L
Measured: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Neutrophil-to-Lymphocyte Ratio (NLR)
The ratio of the absolute neutrophil count to the absolute lymphocyte count, calculated from the routine complete blood count (CBC) to assess the balance of the inflammatory and immune systems.
Unit of Measure: Ratio (unitless)
Measured: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Cardiac Troponin I (cTnI) Levels
Serum concentration of cardiac troponin I (cTnI) measured as a specific biomarker for myocardial injury during the perioperative period.
Unit of Measure: ng/mL (or pg/mL per lab standard)
Measured: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Creatine Kinase-MB (CK-MB) Levels
Serum concentration of creatine kinase-MB (CK-MB) isoenzyme, used as a marker for myocardial damage.
Unit of Measure: ng/mL (or U/L per lab standard)
Measured: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Levels
Plasma concentration of NT-proBNP, used as a marker for cardiac wall stress and heart failure severity.
Unit of Measure: pg/mL
Measured: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Serum Cystatin C Levels
Serum concentration of Cystatin C, a sensitive biomarker for early detection of changes in glomerular filtration rate (GFR).
Unit of Measure: mg/L
Measured: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Plasma Interleukin-6 (IL-6) Levels
Plasma concentration of Interleukin-6 (IL-6) measured as a pro-inflammatory cytokine to assess the systemic inflammatory response.Unit of Measure: $pg/mL$
Measured: 24, 48, and 72 hours after surgery.
Postoperative Plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) Levels
Plasma concentration of NGAL, a sensitive biomarker for the early detection of acute kidney injury (AKI).
Unit of Measure: ng/mL
Measured: 24, 48, and 72 hours after surgery.
Expression Level of α7nAChR on CD14+ Monocytes by Flow Cytometry
The surface expression level of alpha-7 nicotinic acetylcholine receptor (α7nAChR) on CD14+ monocytes will be measured. Peripheral blood mononuclear cells (PBMC) are isolated from EDTA-anticoagulated blood. Measurement is performed using a CytoFLEX flow cytometer and analyzed with FlowJo software.
Unit of Measure: Mean Fluorescence Intensity (MFI)
Measured: 24, 48, and 72 hours after surgery.
Percentage of IL-6+ CD14+ Monocytes by Flow Cytometry
The proportion of CD14+ monocytes expressing intracellular Interleukin-6 (IL-6). Measurement is performed using a CytoFLEX flow cytometer and analyzed with FlowJo software.
Unit of Measure: Percentage of CD14+ cells
Measured: 24, 48, and 72 hours after surgery.
Percentage of Th17 Cells in CD4+ T Cells by Flow Cytometry
The proportion of Th17 cells (defined as CD3+CD4+IL-17A+) within the CD4+ T-lymphocyte population. Measurement is performed using a CytoFLEX flow cytometer and analyzed with FlowJo software.
Unit of Measure: Percentage of CD4+ T cells
Measured: 24, 48, and 72 hours after surgery.
Percentage of Treg Cells in CD4+ T Cells by Flow Cytometry
The proportion of Regulatory T cells (Treg, defined as CD3+CD4+CD25+CD127low/-) within the CD4+ T-lymphocyte population. Measurement is performed using a CytoFLEX flow cytometer and analyzed with FlowJo software.
Unit of Measure: Percentage of CD4+ T cells
Measured: 24, 48, and 72 hours after surgery.
Ratio of Th17 Cells to Treg Cells
The ratio of the percentage of Th17 cells to the percentage of Treg cells, calculated from flow cytometry data (CytoFLEX/FlowJo) to assess immune homeostasis.
Unit of Measure: Ratio (unitless)
Measured: 24, 48, and 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start27 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Chen, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549243
- Sponsor's protocol ID
- 20260315122240876
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation for Preventing Acute Kidney Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07549243
- Acronym / sponsor ID
- 20260315122240876
- Conditions
- Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute kidney injury (AKI) is a common complication after cardiac surgery using cardiopulmonary bypass, leading to longer hospital stays and worse outcomes. Effective preventive therapies are lacking.
This randomized controlled trial investigates whether transcutaneous auricular vagus nerve stimulation (taVNS)-a non-invasive ear stimulation technique-can reduce AKI after cardiac surgery. A total of 152 patients undergoing elective cardiac surgery with cardiopulmonary bypass will be randomly assigned to receive either taVNS or sham stimulation. The intervention begins before surgery and continues daily through postoperative day 5.
The primary outcome is the incidence of AKI within 7 days after surgery. Secondary outcomes include AKI severity, need for dialysis, kidney function recovery, complications, and inflammatory biomarkers.
This study is approved by the institutional ethics committee. All participants will provide written informed consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham Stimulation | Sham comparator | Device: Sham Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationParticipants in this arm receive active transcutaneous auricular vagus nerve stimulation (ta-VNS) using the tVNS501 device. Stimulation is delivered to the left cymba conchae (auricular branch of the vagus nerve) with the following parameters: frequency 25 Hz, pulse width 250 µs, 30 seconds on / 30 seconds off cycling. Intensity is adjusted starting from 0.4 V and increased in 0.4 V increments until the participant perceives mild discomfort, then reduced to the highest tolerable non-painful level. The intervention begins on the day of surgery (from the preoperative holding area through 6 hours postoperatively in the ICU) and continues on postoperative days 1 through 5 with two 120-minute sessions per day (at 9:00 and 14:00). The device is applied by trained non-blinded operators. | Device | Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
| Sham StimulationParticipants in this arm receive sham stimulation using the same tVNS501 device. Electrodes are placed on the left cymba conchae following the same procedure as the active group, but no electrical current is delivered. The stimulation settings are displayed on the device to maintain blinding, but the output is turned off. The schedule and duration of device application are identical to those in the active stimulation group. | Device | Sham Stimulation |
Primary outcome
Incidence of Acute Kidney Injury (AKI) Within 7 Days After Surgery
Time frame: Within 7 days after surgery
33 secondary outcomes
Severity of Acute Kidney Injury (AKI) by KDIGO Stage
Time frame: Within 7 days after surgery
Requirement of Renal Replacement Therapy (RRT)
Time frame: From surgery to hospital discharge, assessed daily, up to 90 days
Duration of RRT
Time frame: From initiation to discontinuation of RRT, assessed daily, up to 90 days
Persistent AKI at Postoperative Day 7
Time frame: Postoperative day 7
Time to Kidney Function Recovery Among Participants With AKI
Time frame: From AKI diagnosis to recovery, assessed daily, up to 30 days after surgery
Serum Creatinine Level at 30 Days After Surgery
Time frame: At postoperative day 30
Estimated Glomerular Filtration Rate (eGFR) at 30 Days Post-Surgery
Time frame: At postoperative day 30
Duration of Mechanical Ventilation
Time frame: From the end of surgery until the time of first successful extubation, assessed up to 30 days.
Vasoactive-Inotropic Score (VIS) - Peak and Mean Values
Time frame: Within the first 7 postoperative days, assessed daily
Incidence of Postoperative Delirium Within 7 Days After Surgery
Time frame: Daily from postoperative day 1 through day 7
Change in Mini-Mental State Examination (MMSE) Score From Baseline
Time frame: Preoperative day 1, postoperative day 3, and postoperative day 7
Sleep Quality Assessed by Richards-Campbell Sleep Questionnaire (RCSQ)
Time frame: Preoperative day 1 (baseline), postoperative day 1 morning (assessing night of surgery), and postoperative day 3 morning (assessing night of day 2)
Quality of Recovery Measured by QoR-15 Questionnaire
Time frame: Preoperative day 1, postoperative day 1, postoperative day 3, and postoperative day 7
Postoperative Pain Intensity Measured by Numeric Rating Scale (NRS)
Time frame: Within the first 48 postoperative hours (assessed at least daily)
Total Postoperative Opioid Consumption
Time frame: Within the first 48 postoperative hours
Heart Rate Variability (HRV) Parameters
Time frame: Preoperative, 24 hours, 48 hours, and 72 hours post-surgery
Incidence of Perioperative Complications
Time frame: Within 30 days after surgery
Hospital Length of Stay
Time frame: From surgery admission to hospital discharge, assessed daily, up to 90 days
Intensive Care Unit (ICU) Length of Stay
Time frame: From ICU admission after surgery to ICU discharge, assessed daily, up to 30 days
Readmission Rate
Time frame: Within 30 days after discharge
Postoperative Serum C-reactive Protein (CRP) Levels
Time frame: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Cardiac Troponin I (cTnI) Levels
Time frame: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Creatine Kinase-MB (CK-MB) Levels
Time frame: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Levels
Time frame: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Serum Cystatin C Levels
Time frame: Preoperative (baseline) and daily from postoperative day 1 through day 7.
Postoperative Plasma Interleukin-6 (IL-6) Levels
Time frame: 24, 48, and 72 hours after surgery.
Postoperative Plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) Levels
Time frame: 24, 48, and 72 hours after surgery.
Expression Level of α7nAChR on CD14+ Monocytes by Flow Cytometry
Time frame: 24, 48, and 72 hours after surgery.
Percentage of IL-6+ CD14+ Monocytes by Flow Cytometry
Time frame: 24, 48, and 72 hours after surgery.
Percentage of Th17 Cells in CD4+ T Cells by Flow Cytometry
Time frame: 24, 48, and 72 hours after surgery.
Percentage of Treg Cells in CD4+ T Cells by Flow Cytometry
Time frame: 24, 48, and 72 hours after surgery.
Ratio of Th17 Cells to Treg Cells
Time frame: 24, 48, and 72 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Acute Kidney Injury and Cardiac Surgery, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Kidney Injury (AKI) Within 7 Days After Surgery (time frame: Within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.