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SepsisNCT03475732

Pharmacokinetics of XueBiJing in Patients With Sepsis

A study testing XueBiJing injection in people with Sepsis and Septic Shock, run by Southeast University, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sepsis, Septic Shock, Community Acquired Pneumonia
What is being tested?
XueBiJing injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
18 Mar 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Pharmacokinetic Study of XueBiJing Injection in Patients With Sepsis

Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis

Read the 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.

Being tested
XueBiJing injection
Keywords
XueBiJing injection, Sepsis, Septic shock, Pharmacokinetics
Medical subject headings
Sepsis, Shock, Septic, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XueBiJing injectionDrug

    Also called Tianjin Chase Sun Pharmaceutical Co. LTD

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

Study groups in NCT03475732
Study groupRoleWhat they receive
XueBiJing injectionExperimental100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
Receives: Drug: XueBiJing injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentrations of XueBiJing injection compounds

    Plasma concentrations of XueBiJing injection compounds

    Measured: 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)

  1. Accumulative amounts of XueBiJing compounds in urine

    Accumulative amounts of XueBiJing compounds in urine

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2018
  2. Study start18 Mar 2018
  3. Primary completion30 Jun 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
100mL 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)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03475732
Sponsor's protocol ID
2017ZDSYLL123-P01
Status last verified
Jan 2021
First submitted
18 Mar 2018
Last updated
5 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will work on it.

Publications

  • 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.

    PubMed 17448282

  • 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.

    PubMed 26903338

  • 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.

    PubMed 26838074

  • 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.

    PubMed 26830081

  • 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.

    PubMed 22519600

  • 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.

    PubMed 25038549

  • 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.

    PubMed 24987833

Questions about this trial

What is this clinical trial studying?

A study testing XueBiJing injection in people with Sepsis and Septic Shock, run by Southeast University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentrations of XueBiJing injection compounds (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03475732, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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