Pharmacokinetics of XueBiJing in Patients With Sepsis

Sponsor
Southeast University, China (Other)
Overall Status
Completed
CT.gov ID
NCT03475732
Collaborator
Chinese Academy of Sciences (Other)
35
1
1
21.5
1.6

Study Details

Study Description

Brief Summary

Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

Condition or Disease Intervention/Treatment Phase
  • Drug: XueBiJing injection
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days100mL 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)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic Study of XueBiJing Injection in Patients With Sepsis
Actual Study Start Date :
Mar 18, 2018
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: XueBiJing injection

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
100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
Other Names:
  • Tianjin Chase Sun Pharmaceutical Co. LTD
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongda Hospital, Southeast University Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Southeast University, China
    • Chinese Academy of Sciences

    Investigators

    • Study Director: Chuan Li, Doctor, Shanghai Institute of Materia Medica, Chinese Academy of Sciences,China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Songqiao Liu, Principal Investigator, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT03475732
    Other Study ID Numbers:
    • 2017ZDSYLL123-P01
    First Posted:
    Mar 23, 2018
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Songqiao Liu, Principal Investigator, Southeast University, China
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2021