Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goals of this randomized clinical trial are to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standard intensive care on systemic organ function in septic patients, and exploring its potential mechanisms for improving overall outcomes in sepsis.The main question it aims to answer is whether taVNS can reduce the severity of sepsis patients by ameliorating systemic inflammation.Participants will receive standard intensive care treatment and be randomized to receive the taVNS or sham taVNS as adjuvant treatment twice a day for 7 consecutive days. Several evaluations will be done before and after the intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS group | Experimental | transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days. |
|
| sham-taVNS group | Sham Comparator | sham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS | Device | Transcutaneous Auricular Vagus Nerve Stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SOFA socre | The total SOFA score is obtained by adding the scores of the six systems: respiratory, coagulation, liver, cardiovascular, central nervous, and renal. The SOFA score ranges from 0 to 24, with a higher score indicating more severe organ dysfunction. | Baseline and Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| blood | Routine complete blood count | Baseline and Day 8 |
| Glasgow coma scale | pecific scoring criteria were established for eye opening, verbal response, and motor response, with maximum scores of 4, 5, and 6 points respectively. A higher score indicating better condition. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Yang, PhD | Contact | +8618580262250 | YHeasun@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Army Medical University | Recruiting | Chongqing | China |
1year after publishing this research paper
anyone who are intrested in this research
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 24, 2025 | Jun 30, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sham-taVNS |
| Device |
sham transcutaneous auricular vagus nerve stimulation |
|
| Baseline and Day 8 |
| tidal volume | tested by mechanical ventilation | Baseline and Day 8 |
| vasoactive-intropic score | VIS can intuitively reflect the degree of dependence of sepsis patients on vasoactive drugs, providing a quantitative indicator for clinicians. It helps to more accurately assess the condition of sepsis, evaluate the therapeutic effect and predict the prognosis. The larger the value, the more severe the condition. | Baseline and Day 8 |
| Arterial blood gas (ABG) analysis | Arterial blood gas (ABG) analysis | Baseline and Day 8 |
| fraction of inspiration O2 | tested by mechanical ventilation | Baseline and Day 8 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |