Community Acquired Pneumonia, Sepsis, Septic Shock
Conditions
Keywords
XueBiJing injection, Sepsis, Septic shock, Pharmacokinetics
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 research on this herbal injection has been conducted in healthy human subjects, and the major circulating XueBiJing compounds, as well as their systemic exposure levels and forms and pharmacokinetic characteristics, have been identified. However, it is known that sepsis may induce hepatic, renal and cardiac dysfunction, alter drug metabolizing enzymes and transporters activities, increase capillary permeability, and induce various pathophysiological changes. All these will affect the concentrations at the action sites and pharmacokinetic characteristics of XueBiJing compounds, which contribute to the injection's overall therapeutic action, thus influencing the anti-septic efficacy of the injection. The purpose of this prospective, open label study is to identify the circulating XueBiJing compounds in patients with sepsis after intravenously dosing XueBiJing injection and their systemic exposure forms and levels, pharmacokinetic characteristics, and the associated inter-patient differences of these XueBiJing compounds.
Interventions
100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
Sponsors
Chinese Academy of Sciences
Southeast University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of XueBiJing injection compounds | On 1stand 5th day of giving XueBiJing injection: pre-dose, 1.25 h after starting the infusion, and 0.5, 1, 2, 4, and 8 h after terminating the infusion On 2nd to 4th day of giving XueBiJing injection: pre-dose and 1.25 h after starting the infusion | Plasma concentrations of XueBiJing injection compounds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accumulative amounts of XueBiJing compounds in urine | On 1st day of giving XueBiJing injection: pre-dose and 0-3.25 and 3.25-12 h after starting the infusion On 5thday of giving XueBiJing injection:0-3.25 and 3.25-12 h after starting the infusion | Accumulative amounts of XueBiJing compounds in urine |
Countries
China
Outcome results
None listed