Pharmacokinetics of XueBiJing in Patients With Sepsis

Not Applicable

Completed

• Conditions: Septic Shock; Sepsis; Community Acquired Pneumonia
• Interventions: Drug: XueBiJing injection

• Registration Number: NCT03475732
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study Start: 2018-03-18
• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-18
• Study First Posted: 2018-03-23
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-01
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China