The Efficacy of Xuebijing Injection on Sepsis

Southeast University, China1,817 enrolled

Overview

The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,817

Conditions

Sepsis

Interventions

Xuebijing InjectionDRUG

100ml Xuebijing Injection every 12 hours for 5 days

normal salineDRUG

200ml normal saline every 12 hours for 5 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongda Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

All-Cause Mortality

Death from all causes at 28-days

Time frame: 28 Days after randomization

Secondary Outcomes

Death in ICU

Death from all causes at ICU discharge

Time frame: 28 Days after randomization

SOFA score

Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome

Time frame: Day 0,3,6 after randomization

APACHEⅡ

Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)

Time frame: Day 0,3,6 after randomization

Duration of mechanical ventilation

Duration of mechanical ventilation in ICU

Time frame: 28 days after randomization

ICU stay

Duration of stay in ICU

Time frame: 28 days after randomization

Concentration of C-reactive protein

C-reactive protein at 0, 3,6 days after randomization

Time frame: 0,3,6days after randomization

Concentration of Procalcitonin

Procalcitonin at 0,3,6days after randomization

Time frame: 0,3,6 days after randomization

Percentage of Human Leukocyte Antigen-DR

Data from ClinicalTrials.gov

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