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The Efficacy of Xuebijing Injection on Sepsis

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xuebijing Injection
normal saline
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Xuebijing Injection, morality, sepsis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients will be eligible for inclusion if all of the inclusion criteria are met

  1. Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM)
  2. 18≤ age ≤75years
  3. 2 ≤SOFA ≤13
  4. obtain informed consent

Exclusion Criteria:

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

Sites / Locations

  • Zhongda Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group

Placebo group

Arm Description

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

normal saline 200 mL every 12 hours for 5 days

Outcomes

Primary Outcome Measures

All-Cause Mortality
Death from all causes at 28-days

Secondary Outcome Measures

Death in ICU
Death from all causes at ICU discharge
SOFA score
Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome
APACHEⅡ
Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)
Duration of mechanical ventilation
Duration of mechanical ventilation in ICU
ICU stay
Duration of stay in ICU
Concentration of C-reactive protein
C-reactive protein at 0, 3,6 days after randomization
Concentration of Procalcitonin
Procalcitonin at 0,3,6days after randomization
Percentage of Human Leukocyte Antigen-DR
Human Leukocyte Antigen-DR at 0, 6 days after randomization

Full Information

First Posted
July 29, 2017
Last Updated
January 1, 2021
Sponsor
Southeast University, China
Collaborators
National Health and Family Planning Commission, P.R.China
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1. Study Identification

Unique Protocol Identification Number
NCT03238742
Brief Title
The Efficacy of Xuebijing Injection on Sepsis
Official Title
The Efficacy of Xuebijing Injection in Adult Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
July 28, 2019 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
National Health and Family Planning Commission, P.R.China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Efficacy of Xuebijing Injection in Adult Patients with Sepsis
Detailed Description
The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment provides significant mortality reduction improvement in patients with sepsis compared with placebo treatment in patients receiving the current standard of care for sepsis. This study will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in patients with sepsis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Xuebijing Injection, morality, sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Blind (Participant, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
1817 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
normal saline 200 mL every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Xuebijing Injection
Intervention Description
100ml Xuebijing Injection every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS
Intervention Description
200ml normal saline every 12 hours for 5 days
Primary Outcome Measure Information:
Title
All-Cause Mortality
Description
Death from all causes at 28-days
Time Frame
28 Days after randomization
Secondary Outcome Measure Information:
Title
Death in ICU
Description
Death from all causes at ICU discharge
Time Frame
28 Days after randomization
Title
SOFA score
Description
Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome
Time Frame
Day 0,3,6 after randomization
Title
APACHEⅡ
Description
Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)
Time Frame
Day 0,3,6 after randomization
Title
Duration of mechanical ventilation
Description
Duration of mechanical ventilation in ICU
Time Frame
28 days after randomization
Title
ICU stay
Description
Duration of stay in ICU
Time Frame
28 days after randomization
Title
Concentration of C-reactive protein
Description
C-reactive protein at 0, 3,6 days after randomization
Time Frame
0,3,6days after randomization
Title
Concentration of Procalcitonin
Description
Procalcitonin at 0,3,6days after randomization
Time Frame
0,3,6 days after randomization
Title
Percentage of Human Leukocyte Antigen-DR
Description
Human Leukocyte Antigen-DR at 0, 6 days after randomization
Time Frame
0，6 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for inclusion if all of the inclusion criteria are met Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM) 18≤ age ≤75years 2 ≤SOFA ≤13 obtain informed consent Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiu Haibo, Dr.
Organizational Affiliation
Southeast University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Mortality
IPD Sharing Time Frame
Study published
IPD Sharing Access Criteria
Supplyment
Citations:
PubMed Identifier
31467049
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Review& Education
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/26903338
Available IPD/Information Identifier
2
Available IPD/Information Comments
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;315(8):801-10.

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The Efficacy of Xuebijing Injection on Sepsis

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