Pharmacokinetics of XueBiJing in Patients With Sepsis

Study Overview
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Brief Summary
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Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

Detailed Description
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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.

Official Title
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Pharmacokinetic Study of XueBiJing Injection in Patients With Sepsis

Conditions
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Sepsis, Septic Shock, Community Acquired Pneumonia

Intervention / Treatment
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* Drug: XueBiJing injection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XueBiJing injection<br>100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days | Drug: XueBiJing injection<br>* 100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days<br>* Other names: Tianjin Chase Sun Pharmaceutical Co. LTD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of XueBiJing injection compounds | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulative amounts of XueBiJing compounds in urine | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XueBiJing injection, Sepsis, Septic shock, Pharmacokinetics