Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions（EXIT-SEP REAL）

Southeast University, China

Status: Not yet enrolling

Conditions: Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT07069894

2025ZDSYLL252-P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,400 participants in 1 patient group

Xuebijing Group

Description:

The Xuebijing group consisted of sepsis patients who received both Xuebijing injection and guideline-concordant therapy. Researchers did not provide any additional interventions, but instead observed and documented the clinical outcomes and treatment effects of Xuebijing injection in combination with standard therapy.