The Efficacy of Xuebijing Injection on Sepsis

Study Overview
=================
Brief Summary
-----------------
The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

Detailed 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.

Official Title
-----------------
The Efficacy of Xuebijing Injection in Adult Patients With Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Xuebijing Injection
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be eligible for inclusion if all of the inclusion criteria are met Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM) 18≤ age ≤75years 2 ≤SOFA ≤13 obtain informed consent Exclusion Criteria: Diagnosis of sepsis for more than 48 h; Pregnant and lactating women; Severe primary disease including unrespectable tumours, blood diseases and Human Immunodeficiency Virus (HIV); Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points); Use of an immunosuppressant or having an organ transplant within the previous 6 months; Participating in other clinical trials in the previous 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion. | Drug: Xuebijing Injection<br>* 100ml Xuebijing Injection every 12 hours for 5 days<br>|
| Placebo Comparator: Placebo group<br>normal saline 200 mL every 12 hours for 5 days | Drug: normal saline<br>* 200ml normal saline every 12 hours for 5 days<br>* Other names: NS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | Death from all causes at 28-days | 28 Days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death in ICU | Death from all causes at ICU discharge | 28 Days after randomization | 
| SOFA score | Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome | 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) | Day 0,3,6 after randomization | 
| Duration of mechanical ventilation | Duration of mechanical ventilation in ICU | 28 days after randomization | 
| ICU stay | Duration of stay in ICU | 28 days after randomization | 
| Concentration of C-reactive protein | C-reactive protein at 0, 3,6 days after randomization | 0,3,6days after randomization | 
| Concentration of Procalcitonin | Procalcitonin at 0,3,6days after randomization | 0,3,6 days after randomization | 
| Percentage of Human Leukocyte Antigen-DR | Human Leukocyte Antigen-DR at 0, 6 days after randomization | 0，6 days after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xuebijing Injection, morality, sepsis