Sepsis
Conditions
Interventions
Dexmedetomidine group:In the experimental group, dexmedetomidine was administered via continuous intravenous infusion at an initial rate of 0.2 µg/(kg·h), without a loading dose.
Based on the depth of
Saline group:The saline group received an equivalent volume of normal saline infusion, maintaining blinding and identical infusion duration and rate.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years old; 2. Meeting the diagnostic criteria for sepsis as defined in the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); 3. Undergoing non-cardiac surgery in the emergency department; 4. Transferred to the ICU after surgery and expected to require ICU monitoring or sedation for >= 48 hours; 5. Patients with sepsis complicated with shock can be enrolled only after completing early goal-directed therapy (EGDT) and having relatively stable hemodynamics (norepinephrine dose < 0.5 µg·kg^-1·min^-1).
Exclusion criteria
Exclusion criteria: 1. Allergy to dexmedetomidine or alpha2 receptor agonists; 2. Severe arrhythmia (degree II/III) with no available pacemaker; 3. Severe hypotension or unable to tolerate possible blood pressure drop; 4. Severe liver failure (Child-Pugh C) or expected survival < 24 hours; 5. Pregnant or breastfeeding; 6. Participating in other interventional clinical trials or using biological agents that may interfere with immune assessment recently; 7. Having an immune disorder or using immunosuppressants; 8. Patients with confirmed hematological diseases; 9. Patients who received radiotherapy or chemotherapy within 30 days before sepsis; 10. Human immunodeficiency virus infection; 11. Post organ transplantation; 12. Refusing to participate in this study or incomplete medical records; 13. Patients with immune diseases, those who have used systemic immunosuppressants (such as glucocorticoids, etc.) or are currently undergoing treatment with immune checkpoint inhibitors; 14. Patients who have been clearly excluded from active malignant tumors and have received radiotherapy, chemotherapy or targeted immunotherapy within 3 months before the occurrence of sepsis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The SOFA score on the 7th day after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality;Change in SOFA score at 48 hours after enrollment;HLA-DR expression on peripheral blood mononuclear cells;Proportions of peripheral blood lymphocyte subsets;Expression levels of inflammatory cytokines;Immunosuppressive markers; | — |
Countries
China
Contacts
Public ContactChanghong Miao
Zhongshan Hospital, Fudan University
Outcome results
None listed