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

ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSoutheast University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalized patients aged ≥18 years

Sepsis diagnosis meeting Sepsis-3 criteria

Informed consent signed by patient or legally authorized representative

Disqualifiers

Patients with a prior history of sepsis

Sepsis diagnosis >48 hours prior to enrollment

Current participation in clinical trial

Trial population

Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,400 Participants
are grouped into 1 trial group
Group A: Xuebijing Group

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southeast University, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: