Health TrialsbyHealthPanel

Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients

ConditionSepsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThird Military Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80

Sepsis was diagnosed per the Sepsis-3 criteria (SCCM/ESICM 2016) as infection with SOFA score ≥ 2

ICU admission within 7 days after sepsis onset

Informed consent was obtained from patients/guardians

Disqualifiers

severe ARDS defined by PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cm H₂O

HR>120 per minute

epinephrine or norepinephrine >1ug/kg/min

severe underlying pulmonary diseases including interstitial lung disease, -

Trial design

Design model

Parallel

Treatments tested in this trial

  • taVNS

    Device

    Transcutaneous Auricular Vagus Nerve Stimulation

  • sham-taVNS

    Device

    sham transcutaneous auricular vagus nerve stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: taVNS groupExperimental treatment 1 intervention
Group B: sham-taVNS groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and Day 8

Secondary outcomes

1

blood

Routine complete blood count

Time frame
Baseline and Day 8
2

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.

Time frame
Baseline and Day 8
3

tidal volume

tested by mechanical ventilation

Time frame
Baseline and Day 8
4

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.

Time frame
Baseline and Day 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Military Medical University

Lead sponsor

Source ClinicalTrials.gov
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