The Efficacy of Xuebijing Injection on Sepsis

Southeast University, China

Status and phase: Completed; Phase 4

Conditions: Sepsis

Treatments: Drug: Xuebijing Injection; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03238742

2017ZDSYLL025-P01

Details and patient eligibility

About

The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

Full description

The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment provides significant mortality reduction improvement in patients with sepsis compared with placebo treatment in patients receiving the current standard of care for sepsis. This study will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in patients with sepsis.

Enrollment: 1,817 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients will be eligible for inclusion if all of the inclusion criteria are met

1. Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM)
2. 18≤ age ≤75years
3. 2 ≤SOFA ≤13
4. obtain informed consent

Exclusion criteria

1. Diagnosis of sepsis for more than 48 h;
2. Pregnant and lactating women;
3. Severe primary disease including unrespectable tumours, blood diseases and Human Immunodeficiency Virus (HIV);
4. Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points);
5. Use of an immunosuppressant or having an organ transplant within the previous 6 months;
6. Participating in other clinical trials in the previous 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,817 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.

Treatment:

Drug: Xuebijing Injection

Placebo group

Placebo Comparator group

Description:

normal saline 200 mL every 12 hours for 5 days

Treatment:

Drug: normal saline