Pharmacokinetics of XueBiJing in Patients With Sepsis

NCT03475732 | Completed DMC

• 1 other identifier: 2017ZDSYLL123-P01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

Conditions

Sepsis; Septic Shock; Community Acquired Pneumonia

Keywords

XueBiJing injection; Sepsis; Septic shock; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (1)

XueBiJing injection

EXPERIMENTAL

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

Interventions

XueBiJing injection DRUG

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

Also known as: Tianjin Chase Sun Pharmaceutical Co. LTD

XueBiJing injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Southeast University, China: lead
• Chinese Academy of Sciences: collaborator

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (7)

• Li YP, Qiao YJ, Wu ZX, Yao YM, Yu Y, Wu Y. [Effects of Xuebijing injection on high-mobility group box chromosomal protein 1 in septic rats]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2007 Apr;19(4):239-41. No abstract available. Chinese.

  PMID: 17448282 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Cheng C, Lin JZ, Li L, Yang JL, Jia WW, Huang YH, Du FF, Wang FQ, Li MJ, Li YF, Xu F, Zhang NT, Olaleye OE, Sun Y, Li J, Sun CH, Zhang GP, Li C. Pharmacokinetics and disposition of monoterpene glycosides derived from Paeonia lactiflora roots (Chishao) after intravenous dosing of antiseptic XueBiJing injection in human subjects and rats. Acta Pharmacol Sin. 2016 Apr;37(4):530-44. doi: 10.1038/aps.2015.103. Epub 2016 Feb 1.

  PMID: 26838074 BACKGROUND

• Li X, Cheng C, Wang F, Huang Y, Jia W, Olaleye OE, Li M, Li Y, Li C. Pharmacokinetics of catechols in human subjects intravenously receiving XueBiJing injection, an emerging antiseptic herbal medicine. Drug Metab Pharmacokinet. 2016 Feb;31(1):95-98. doi: 10.1016/j.dmpk.2015.10.005. Epub 2015 Nov 4.

  PMID: 26830081 BACKGROUND

• Sinnollareddy MG, Roberts MS, Lipman J, Roberts JA. beta-lactam pharmacokinetics and pharmacodynamics in critically ill patients and strategies for dose optimization: a structured review. Clin Exp Pharmacol Physiol. 2012 Jun;39(6):489-96. doi: 10.1111/j.1440-1681.2012.05715.x.

  PMID: 22519600 BACKGROUND

• Blot SI, Pea F, Lipman J. The effect of pathophysiology on pharmacokinetics in the critically ill patient--concepts appraised by the example of antimicrobial agents. Adv Drug Deliv Rev. 2014 Nov 20;77:3-11. doi: 10.1016/j.addr.2014.07.006. Epub 2014 Jul 15.

  PMID: 25038549 BACKGROUND

• Harvey RD, Morgan ET. Cancer, inflammation, and therapy: effects on cytochrome p450-mediated drug metabolism and implications for novel immunotherapeutic agents. Clin Pharmacol Ther. 2014 Oct;96(4):449-57. doi: 10.1038/clpt.2014.143. Epub 2014 Jul 2.

  PMID: 24987833 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Community-Acquired Pneumonia

Interventions

Xuebijing

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Chuan Li, Doctor

  Shanghai Institute of Materia Medica, Chinese Academy of Sciences,China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 23, 2018
• Study Start: March 18, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

CN (1)