Status:
COMPLETED
The Efficacy of Xuebijing Injection on Sepsis
Lead Sponsor:
Southeast University, China
Collaborating Sponsors:
National Health and Family Planning Commission, P.R.China
Conditions:
Sepsis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
1817 Patients enrolled
Trial Details
Trial ID
NCT03238742
Start Date
October 20 2017
End Date
January 8 2020
Last Update
January 5 2021
Active Locations (1)
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1
Zhongda Hospital
Nanjing, Jiangsu, China, 210009