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| Name | Class |
|---|---|
| National Health and Family Planning Commission, P.R.China | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion. |
|
| Placebo group | Placebo Comparator | normal saline 200 mL every 12 hours for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuebijing Injection | Drug | 100ml Xuebijing Injection every 12 hours for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Death from all causes at 28-days | 28 Days after randomization |
| 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 |
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Inclusion Criteria:
Patients will be eligible for inclusion if all of the inclusion criteria are met
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiu Haibo, Dr. | Southeast University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40666169 | Derived | Lou X, Chen H, Shi N, Yu R, Li S, Yang Y, Liu S, Xie J, Qiu H. Treatment effects of Xuebijing injection in patients with sepsis by clinical phenotype: a post hoc analysis of the EXIT-SEP trial. EClinicalMedicine. 2025 Jul 9;86:103341. doi: 10.1016/j.eclinm.2025.103341. eCollection 2025 Aug. | |
| 37126332 | Derived |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 2 | Clinical Review& Education | View IPD |
Mortality
Study published
Supplyment
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C549376 | Xuebijing |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Parallel Assignment
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Blind (Participant, Investigator, Outcomes Assessor)
| normal saline |
| Drug |
200ml normal saline every 12 hours for 5 days |
|
|
| 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 |
| Liu S, Yao C, Xie J, Liu H, Wang H, Lin Z, Qin B, Wang D, Lu W, Ma X, Liu Y, Liu L, Zhang C, Xu L, Zheng R, Zhou F, Liu Z, Zhang G, Zhou L, Liu J, Fei A, Zhang G, Zhu Y, Qian K, Wang R, Liang Y, Duan M, Wu D, Sun R, Wang Y, Zhang X, Cao Q, Yang M, Jin M, Song Y, Huang L, Zhou F, Chen D, Liang Q, Qian C, Tang Z, Zhang Z, Feng Q, Peng Z, Sun R, Song Z, Sun Y, Chai Y, Zhou L, Cheng C, Li L, Yan X, Zhang J, Huang Y, Guo F, Li C, Yang Y, Shang H, Qiu H; EXIT-SEP Investigators. Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis: The EXIT-SEP Randomized Clinical Trial. JAMA Intern Med. 2023 Jul 1;183(7):647-655. doi: 10.1001/jamainternmed.2023.0780. |
| 31467049 | Derived | Liu S, Yao C, Zhang J, Yang Y, Qiu H; EXIT-SEP Investigators. Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP): protocol for a randomised controlled trial. BMJ Open. 2019 Aug 28;9(8):e028664. doi: 10.1136/bmjopen-2018-028664. |
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC.The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801-10. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |