NCT03238742

Brief Summary

The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,817

participants targeted

Target at P75+ for phase_4 sepsis

Timeline
Completed

Started Oct 2017

Typical duration for phase_4 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

July 29, 2017

Last Update Submit

January 1, 2021

Conditions

Sepsis

Keywords

Xuebijing Injection, morality, sepsis

Outcome Measures

Primary Outcomes (1)

  • All-Cause Mortality

    Death from all causes at 28-days

    28 Days after randomization

Secondary Outcomes (8)

  • Death in ICU

    28 Days after randomization

  • SOFA score

    Day 0,3,6 after randomization

  • APACHEⅡ

    Day 0,3,6 after randomization

  • Duration of mechanical ventilation

    28 days after randomization

  • ICU stay

    28 days after randomization

  • +3 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.

Drug: Xuebijing Injection

Placebo group

PLACEBO COMPARATOR

normal saline 200 mL every 12 hours for 5 days

Drug: normal saline

Interventions

Xuebijing InjectionDRUG

100ml Xuebijing Injection every 12 hours for 5 days

Intervention Group
normal salineDRUG

200ml normal saline every 12 hours for 5 days

Also known as: NS
Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM)
  • ≤ age ≤75years
  • ≤SOFA ≤13
  • obtain informed consent

You may not qualify if:

  • Diagnosis of sepsis for more than 48 h;
  • Pregnant and lactating women;
  • Severe primary disease including unrespectable tumours, blood diseases and Human Immunodeficiency Virus (HIV);
  • Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points);
  • Use of an immunosuppressant or having an organ transplant within the previous 6 months;
  • Participating in other clinical trials in the previous 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

Related Publications (3)

  • Lou X, Chen H, Shi N, Yu R, Li S, Yang Y, Liu S, Xie J, Qiu H. Treatment effects of Xuebijing injection in patients with sepsis by clinical phenotype: a post hoc analysis of the EXIT-SEP trial. EClinicalMedicine. 2025 Jul 9;86:103341. doi: 10.1016/j.eclinm.2025.103341. eCollection 2025 Aug.

    PMID: 40666169DERIVED

  • Liu S, Yao C, Xie J, Liu H, Wang H, Lin Z, Qin B, Wang D, Lu W, Ma X, Liu Y, Liu L, Zhang C, Xu L, Zheng R, Zhou F, Liu Z, Zhang G, Zhou L, Liu J, Fei A, Zhang G, Zhu Y, Qian K, Wang R, Liang Y, Duan M, Wu D, Sun R, Wang Y, Zhang X, Cao Q, Yang M, Jin M, Song Y, Huang L, Zhou F, Chen D, Liang Q, Qian C, Tang Z, Zhang Z, Feng Q, Peng Z, Sun R, Song Z, Sun Y, Chai Y, Zhou L, Cheng C, Li L, Yan X, Zhang J, Huang Y, Guo F, Li C, Yang Y, Shang H, Qiu H; EXIT-SEP Investigators. Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis: The EXIT-SEP Randomized Clinical Trial. JAMA Intern Med. 2023 Jul 1;183(7):647-655. doi: 10.1001/jamainternmed.2023.0780.

    PMID: 37126332DERIVED

  • Liu S, Yao C, Zhang J, Yang Y, Qiu H; EXIT-SEP Investigators. Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP): protocol for a randomised controlled trial. BMJ Open. 2019 Aug 28;9(8):e028664. doi: 10.1136/bmjopen-2018-028664.

    PMID: 31467049DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

XuebijingSaline Solution

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Qiu Haibo, Dr.

    Southeast University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blind (Participant, Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 29, 2017

First Posted

August 3, 2017

Study Start

October 20, 2017

Primary Completion

July 28, 2019

Study Completion

January 8, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Mortality

Shared Documents
STUDY PROTOCOL
Time Frame
Study published
Access Criteria
Supplyment

Available IPD Datasets

Clinical Review& Education (2)Access

Locations

CN(1)