sepsis and septic shock
Conditions
Interventions
Lipoic acid injection group:Conventional treatment plus lipoic acid injection
Placebo group:Routine treatment plus placebo
Sponsors
Maoming People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. It conforms to Sepsis-3 diagnostic criteria established by American Society of Critical Care Medicine (SCCM)/ European Society of Critical Care Medicine (ESICM); ? Suspected or confirmed infection: diagnosis by clinician ? Evidence of acute organ dysfunction: 1) For patients without chronic organ dysfunction in the past: (assuming that their baseline SOFA score is 0), SOFA increased by >= 2 points from 48 hours before infection diagnosis to 24 hours after infection diagnosis. 2) For patients with chronic organ dysfunction in the past (SOFA score should be made according to the baseline situation), SOFA increased by >= 2 points from 48 hours before infection diagnosis to 24 hours after infection diagnosis. 3. No more than 48 hours after diagnosis of sepsis; 4. The subject (or his legal representative) has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Female patients during pregnancy or lactation; 2. Persistent sources of infection that cannot be removed by puncture and drainage, debridement or other surgical operations; 3. Patients who are participating in clinical trials of other drugs; 4. The patient is being treated with other foods or drugs with antioxidant effects such as vitamin C and vitamin E; 5. Complicated with non-infectious but life-threatening serious diseases, such as advanced tumors, extremely severe craniocerebral injury, uncontrollable massive hemorrhage, cardiogenic shock, etc.; 6. Disagree with comprehensive and active life support treatment; 7. Patients who are allergic to lipoic acid or similar drugs (B vitamins) and patients who have been intolerant of the recommended dose of lipoic acid in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| ICU mortality;Hospital mortality;ICU stay time;Hospitalization time;Incidence of new AKI after entering ICU;The score of SOFA/APACHE II and its change value from baseline (? SOFA/? Apache II) on D1, D3, D5 and D7 after random grouping;Demand and duration of life support therapy (vasopressors, invasive mechanical ventilation and continuous renal replacement therapy);The LAC concentration of arterial blood on D1, D3, D5 and D7 and its change value from baseline (? LAC) after random grouping;The levels of PCT, hs-CRP, IL-2, IL-4, IL-6, TNF-a, IL-10 and IFN-? on D1, D3, D5 and D7 after random grouping and their changes from baseline; | — |
Countries
China
Contacts
Public ContactChunbo Chen
Maoming People's Hospital
Outcome results
None listed