Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions: A Patient Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 5,400
- Locations
- 1
- Primary Endpoint
- 28-day all-cause mortality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
28-day all-cause mortality
Time Frame: 28 days after enrollment
Secondary Outcomes
- ICU mortality(From Intensive Care Unit (ICU) admission to ICU discharge or death, up to 28 days.)
- ICU-free days within 28 days(28 days after enrollment)
- Ventilator-free days(28 days after enrollment)
Investigators
Songqiao Liu
Prof
Southeast University, China