An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation and Sham Stimulation in Acute Kidney Injury, Cardiac Surgery and Cardiopulmonary Bypass, sponsored by Sir Run Run Shaw Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Prevention
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Among 168 studies in Acute Kidney Injury with a site in China — 46 open to participants now, 54 under way, 1 of them phase 3. Acute Kidney Injury · China.
Among the 168 studies in Acute Kidney Injury with a site in China, this one is the 32nd largest by planned enrollment of the 63 interventional ones that give a count, is one of 25 that started in 2026, is one of 39 with no phase, reaches primary completion later than 21 of the 53 other live ones, and was the 150th registered.
1,691 studies on the registry are indexed under Acute Kidney Injury; 393 are open to participants now.
Browse Acute Kidney Injury studies →46 of the 168 studies in Acute Kidney Injury with a site in China are open now. Recruiting first, the newest first:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18+
China National Center for Cardiovascular Diseases · Sites in China
Ages 18+
Jinling Hospital, China · Sites in China
Ages 18–75
China National Center for Cardiovascular Diseases · Sites in China
Ages 18+
Fujian Medical University Union Hospital · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 230 Acute Kidney Injury studies recruiting now, 162 (70%) set no upper age limit and 35 (15%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
168 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 3 · Phase 4 10
First in 2004; this study’s year is marked. 25 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 152 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Median enrollment 152 across the 63 interventional studies, 472 across the 105 observational. Of the 82 that completed or were terminated, 4 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 168 have an industry lead sponsor. The 10 most frequent:
Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.
Sir Run Run Shaw Hospital has 1 study filed under Acute Kidney Injury — fewer than ten, so there is no comparison to draw.
19 of the studies in Acute Kidney Injury with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07850947Second Affiliated Hospital, Zhejiang University, School of MedicineAn Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT | 2026-12 |
| NCT07672860Jinling Hospital, ChinaPerioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors | 2026-12 |
| NCT07602465Zhongda HospitalThe Impact of Blood Pressure Variability During the Induction and Surgical Periods on Postoperative Acute Kidney Injury | 2026-12-01 |
| NCT06939387Zhejiang Provincial People's HospitalDrug-induced Kidney Injury Model | 2026-12-30 |
| NCT04789733The Cleveland ClinicThe GUARDIAN Pilot Trial | 2026-12-31 |
Add all 19 to your calendar (.ics) → With an account.
Among the 168 studies in Acute Kidney Injury with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Device: Sham Stimulation
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.
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.
Incidence of Acute Kidney Injury (AKI) Within 7 Days After Surgery
Time frame: Within 7 days after surgery
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.
Time frame: Within 7 days after surgery
Requirement of Renal Replacement Therapy (RRT)
Proportion of participants requiring acute RRT during index hospitalization.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
Total number of days from the date of surgery to the date of hospital discharge. Unit of measure: days. Measurement tool: hospital medical records.
Time frame: 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.
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
Serum concentration of C-reactive protein (CRP) measured to monitor systemic inflammatory response after cardiac surgery. Unit of Measure: mg/L
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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: $pg/mL$
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 24, 48, and 72 hours after surgery.
PDFs hosted by the registry, ClinicalTrials.gov.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.
Of 249 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 8 months is below that.
Counting every sponsor, half of 267 studies reached it within 26 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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