Sepsis-Associated Intestinal Injury
Conditions
Interventions
Control group :Infusion of the same dose of normal saline through intravenous drip
Sponsors
Suzhou Ninth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 88 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for sepsis and septic shock formulated by the Society of Critical Care Medicine/European Society of ntensive Care Medicine (Sepsis-3 criteria). 2. Aged between 18 and 88 years old, regardless of gender. 3. Enrolled within 48 hours after being diagnosed with sepsis or septic shock. 4. New-onset acute gastrointestinal injury occurs within 72 hours after admission, consistent with ESICM 2012 AGI grade >= grade ?, and confirmed as sepsis-associated acute intestinal injury (SAI). 5. Expected ICU hospitalization duration >=7 days with relatively stable vital signs, capable of completing the whole-course observation and index detection. 6. The patient or legal representative fully understands the study, voluntarily participates in this clinical trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female patients. 2. Patients with persistent infection sources that cannot be effectively eliminated by puncture, drainage, debridement or other surgical procedures. 3. Participants enrolled in other clinical trials, or those who have received other antioxidant drugs such as vitamin C and vitamin E within the past one month. 4. Patients accompanied by non-infectious life-threatening conditions, including severe craniocerebral injury, uncontrollable massive hemorrhage, cardiogenic shock and others. 5. Patients with a history of chronic intestinal diseases, inflammatory bowel disease, intestinal tumors or severe gastrointestinal surgery. 6. Patients allergic to lipoic acid or similar active agents such as B vitamins, or those previously intolerant to lipoic acid at recommended doses. 7. Patients with severe hepatic and renal failure requiring continuous bedside dialysis, end-stage malignant tumors or advanced hematological diseases. 8. Patients with mental disorders or cognitive dysfunction who are unable to cooperate with the study and follow-up visits. 9. Patients with expected death within 72 hours, those who refuse active treatment, or those with incomplete clinical data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal function injury markers (I-FABP, citrulline, D-lactic acid, diamine oxidase, DAO); | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day in-hospital mortality in ICU;Changes in inflammatory and oxidative stress biomarkers (levels of IL-1, IL-4, IL-6, IL-10, TNF-a, MDA, SOD, GSH, total iron and ROS);Mitochondrial function; | — |
Countries
China
Contacts
Public ContactZou Han
Suzhou Ninth People's Hospital
Outcome results
None listed