Status:
COMPLETED
Pharmacokinetics of XueBiJing in Patients With Sepsis
Lead Sponsor:
Southeast University, China
Collaborating Sponsors:
Chinese Academy of Sciences
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis
Detailed Description
XueBiJing injection, a five-herb combination approved by Chinese FDA in 2004, has been widely used as an add-on therapy in routine sepsis care in Chinese clinics. A comprehensive pharmacokinetic resea...
Eligibility Criteria
Inclusion
- 18≤ age ≤70 years old
- Community acquired pneumonia patients who met the Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM) with2 ≤SOFA ≤13
- To use XueBiJing injection as an add-on therapy to treat sepsis decided byclinician
- Informed consent obtained
Exclusion
- Diagnosis of sepsis for over 48 h
- Pregnant or lactating women
- Patients with a history of anaphylaxis or allergyto XueBiJing or its component herbs
- Patients participated in an investigational clinical trial within 30 days prior to this study
- Patients unable or unsuitable to participate in this study decided by the investigator (i.e., patients whose death are deemed within 48 h or who poorly adhere to the treatment)
Key Trial Info
Start Date :
March 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03475732
Start Date
March 18 2018
End Date
December 31 2019
Last Update
January 5 2021
Active Locations (1)
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1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009