Pharmacokinetics of XueBiJing in Patients With Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-18

Study Completion Date

2019-12-31

Brief Summary

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Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

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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.

Conditions

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Sepsis Septic Shock Community Acquired Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XueBiJing injection

100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days

Group Type EXPERIMENTAL

XueBiJing injection

Intervention Type DRUG

100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days

Interventions

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XueBiJing injection

100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days

Intervention Type DRUG

Other Intervention Names

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Tianjin Chase Sun Pharmaceutical Co. LTD

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No