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NCT Number: NCT07069894

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 28-day all-cause mortality

    Time frame: 28 days after enrollment

Secondary outcomes

  1. ICU mortality

    Time frame: From Intensive Care Unit (ICU) admission to ICU discharge or death, up to 28 days.

  2. Ventilator-free days

    Time frame: 28 days after enrollment

  3. ICU-free days within 28 days

    Time frame: 28 days after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Liu Songqiao

CONTACT

[email protected]

+86 25 83262553

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions: A Patient Registry

Acronym: EXIT-SEP REAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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