Sepsis
Conditions
Interventions
Control group:The simulator for internal wire failure of the vagus nerve stimulator is used twice a day, with each session lasting for 60 minutes, alternately applied to the left and right ears, conti
Test group:The vagus nerve stimulator is applied twice a day, with each session lasting for 60 minutes, alternately stimulating the left and right ears. The frequency is set at 25 Hz, and the current
Sponsors
Yancheng Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Age >=18 years. (2) Diagnosed with sepsis according to the Sepsis-3 (2016) criteria. (3) Meet the diagnostic criteria for sepsis-induced coagulopathy (SIC), defined as SIC score >=4 points (platelet count 1.4, and SOFA score >=2). (4) First fulfilment of SIC diagnostic criteria within 24 hours before enrolment. (5) Able to initiate the intervention within 24 hours after randomization. (6) Provision of written informed consent by the patient or a legally authorised representative.
Exclusion criteria
Exclusion criteria: (1) Pregnant or breastfeeding. (2) Active bleeding or a significant tendency to bleed. (3) Confirmed haematologic malignancy (e.g. Myelodysplastic syndrome, leukaemia, lymphoma). (4) Receiving therapeutic-dose anticoagulation (e.g. low molecular weight heparin, warfarin, direct oral anticoagulants); use of prophylactic-dose anticoagulants is permitted. (5) Presence of implantable electronic medical devices (e.g. pacemaker, defibrillator), or anatomical abnormalities of the auricle precluding taVNS. (6) Expected survival time <72 hours. (7) Confirmed or suspected viral infection (e.g. PCR or FilmArray test positive for SARS-CoV-2, EBV, CMV, etc.). (8) Participation in other interventional clinical trials and receipt of study treatment within the past 4 weeks. (9) Inability to provide informed consent and absence of a legal representative. (10) Any other medical or psychological condition that, in the judgement of the investigators, may interfere with study safety, adherence, or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients who demonstrate an improvement of >=2 points in SIC score from baseline to Day 7 post-intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| c-reactive protein;angiopoietin-2;Procalcitonin;Systemic immune inflammation index;lactic acid;Fibrinogen; International Normalized Ratio;Platelet count;activated partial thromboplastin time;D-dimer;IL-6;length of hospital stay;28-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactYin Mingzhu
Yancheng Third People's Hospital
Outcome results
None listed