Pharmacokinetics of XueBiJing in Patients With Sepsis

Southeast University, China

Status

Completed

Conditions

Community Acquired Pneumonia

Septic Shock

Sepsis

Treatments

Drug: XueBiJing injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03475732

2017ZDSYLL123-P01

Details and patient eligibility

About

Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

Full 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.

Enrollment

35 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)