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

Launched by SOUTHEAST UNIVERSITY, CHINA · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called Xuebijing injection (XBJ) can help improve outcomes for patients with sepsis, a serious and life-threatening response to infection. Previous research showed that XBJ helped reduce the chance of death within 28 days, but this new study will look at how well the treatment works in everyday hospital settings with a wider range of patients.

Adults aged 18 and older who are currently in the hospital with sepsis, diagnosed using standard criteria, may be eligible to join the trial. To participate, patients or their legal representatives must agree to take part. People who have had sepsis before, who were diagnosed more than 48 hours ago, or who are already in another clinical trial cannot join. If enrolled, participants will receive the XBJ treatment as part of their care, and doctors will monitor their progress to see if the medicine helps them recover better. This study aims to confirm if XBJ is effective and safe for typical patients outside of tightly controlled research settings.

Gender

ALL

Eligibility criteria

• 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