Sepsis
Conditions
Keywords
Xuebijing Injection, morality, sepsis
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.
Interventions
100ml Xuebijing Injection every 12 hours for 5 days
DRUGnormal saline
200ml normal saline every 12 hours for 5 days
Sponsors
National Health and Family Planning Commission, P.R.China
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Blind (Participant, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 28 Days after randomization | Death from all causes at 28-days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score | Day 0,3,6 after randomization | Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome |
| APACHEⅡ | Day 0,3,6 after randomization | Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points) |
| Duration of mechanical ventilation | 28 days after randomization | Duration of mechanical ventilation in ICU |
| Death in ICU | 28 Days after randomization | Death from all causes at ICU discharge |
| Concentration of C-reactive protein | 0,3,6days after randomization | C-reactive protein at 0, 3,6 days after randomization |
| Concentration of Procalcitonin | 0,3,6 days after randomization | Procalcitonin at 0,3,6days after randomization |
| Percentage of Human Leukocyte Antigen-DR | 0，6 days after randomization | Human Leukocyte Antigen-DR at 0, 6 days after randomization |
| ICU stay | 28 days after randomization | Duration of stay in ICU |
Countries
China
Outcome results
None listed