Sepsis-Associated Acute Gastrointestinal Injury
Conditions
Interventions
sham transcutaneous auricular vagus nerve stimulation (sham taVNS) group:Wear an transcutaneous auricular vagus nerve stimulator, but do not give electrical stimulation
Sponsors
Qilu Hospital of Shandong University (Qingdao)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for sepsis-associated acute gastrointestinal injury (AGI). 2.Expected to stay in the ICU for more than one week after diagnosis. 3.Aged >=18 years, regardless of gender. 4.Indicated for enteral nutrition, with a nutrition risk screening score of 3 to 7. 5.Patient voluntarily agrees or the family consents to participate in the trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Primary disease is a gastrointestinal disorder, such as gastrointestinal ulcers, atrophic gastritis, gastric cancer, etc. 2.Post-gastrointestinal surgery patients. 3.Patients with malignant tumors, end-stage diseases, severe traumatic brain injury, extremely poor prognosis, or those who may die in the short term. 4.Patients with local skin infections that prevent electrode placement. 5.Patients with a permanent cardiac pacemaker. 6.Pregnant or breastfeeding women. 7.Patients unable to maintain a resting state (e.g., those with epilepsy, Parkinson's disease, etc.). 8.Patients or their families who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric Antrum Motility Index (MI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Vagus nerve activity: HRV;Gastric Emptying Time;Enteral Nutrition Compliance Rate;AGI Grading;Enteral Nutrition Tolerance Score;Intra-abdominal Pressure;Incidence of Feeding Intolerance within 7 Days (e.g., vomiting or reflux, abdominal distention, diarrhea, gastrointestinal bleeding, reduced or absent bowel sounds, constipation, gastric residual volume >=500ml/24h, etc.);Incidence of New Infections (e.g., pulmonary, bloodstream, urinary tract, intra-abdominal infections, and other infections);Gastric Residual Volume Measurement;Incidence of Aspiration within 7 Days;Intestinal Barrier Biomarkers:Intestinal Fatty Acid Binding Protein (I-FABP), Diamine Oxidase (DAO), Intercellular Adhesion Molecule-1 (ICAM-1), Zonulin, D-lactate;Gastrointestinal Motility Markers:Motilin (MOT), Gastrin (GAS);Inflammatory Markers:WBC, NEU%, LYM%, CRP, PCT, IL-6, TNF-a;Disease Severity: APACHE II Score , SOFA Score, Duration of Mechanical Ventilation, Duration of CRRT (Continuous Renal Replacement Therapy), Length of Hospital Stay, Length of ICU Stay, Hospital Costs, In-hospital Infections;Organ function: ALT, AST, TBIL, DBIL; BUN, Cr, urine volume, CRRT time; Mechanical ventilation time, P/F; Lac; cTnI, NT-proBNP; PT, Fib, APTT, PLT, D-dimer;Vital Signs: Heart Rate (HR), Blood Pressure (BP), Maximum Temperature (Tmax), Respiratory Rate (RR);Gut Microbiota + Blood Metabolites: Pre- and Post-Intervention;Safety Assessment; | — |
Countries
China
Contacts
Public ContactZhiyang Wu
Qilu Hospital of Shandong University (Qingdao)
Outcome results
None listed