Sepsis
Conditions
Keywords
Sepsis, Xuebijing injection, Intensive Care Unit
Brief summary
Xuebijing injection (XBJ) showed proven efficacy in the EXIT-SEP trial (NCT03238742), lowering 28-day mortality. However, its real-world effectiveness requires validation due to the trial's strict criteria. Broader clinical evaluation is imperative.
Detailed description
Sepsis is a life-threatening syndrome caused by a dysregulated response to infection, affecting an estimated 49 million people and claiming 11 million lives globally each year. Xuebijing injection (XBJ) has demonstrated efficacy in improving outcomes. A large multicenter randomized controlled trial (EXIT-SEP) confirmed that XBJ significantly reduces 28-day mortality. However, the trial population was relatively selected (aged 18-75 years, SOFA score 2-13), leaving its effectiveness in complex, real-world settings unclear. Therefore, further investigation of XBJ's impact in broader clinical practice is essential.
Interventions
None listed
Sponsors
Southeast University, China
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients aged ≥18 years * Sepsis diagnosis meeting Sepsis-3 criteria * Informed consent signed by patient or legally authorized representative
Exclusion criteria
* Patients with a prior history of sepsis * Sepsis diagnosis \>48 hours prior to enrollment * Current participation in clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality | 28 days after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| ICU mortality | From Intensive Care Unit (ICU) admission to ICU discharge or death, up to 28 days. |
| Ventilator-free days | 28 days after enrollment |
| ICU-free days within 28 days | 28 days after enrollment |
Countries
China
Contacts
Primary ContactProfessor Liu Songqiao
Outcome results
None listed