- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03238742
The Efficacy of Xuebijing Injection on Sepsis
January 1, 2021 updated by: Songqiao Liu, Southeast University, China
The Efficacy of Xuebijing Injection in Adult Patients With Sepsis
The Efficacy of Xuebijing Injection in Adult Patients with Sepsis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1817
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Zhongda Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention Group
100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.
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100ml Xuebijing Injection every 12 hours for 5 days
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PLACEBO_COMPARATOR: Placebo group
normal saline 200 mL every 12 hours for 5 days
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200ml normal saline every 12 hours for 5 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-Cause Mortality
Time Frame: 28 Days after randomization
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Death from all causes at 28-days
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28 Days after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death in ICU
Time Frame: 28 Days after randomization
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Death from all causes at ICU discharge
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28 Days after randomization
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APACHEⅡ
Time Frame: Day 0,3,6 after randomization
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Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)
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Day 0,3,6 after randomization
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ICU stay
Time Frame: 28 days after randomization
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Duration of stay in ICU
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28 days after randomization
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SOFA score
Time Frame: Day 0,3,6 after randomization
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Total Sequential Organ Failure Assessment (SOFA) score(0-24) ,higher values represent a worse outcome
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Day 0,3,6 after randomization
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Duration of mechanical ventilation
Time Frame: 28 days after randomization
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Duration of mechanical ventilation in ICU
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28 days after randomization
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Concentration of C-reactive protein
Time Frame: 0,3,6days after randomization
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C-reactive protein at 0, 3,6 days after randomization
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0,3,6days after randomization
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Concentration of Procalcitonin
Time Frame: 0,3,6 days after randomization
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Procalcitonin at 0,3,6days after randomization
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0,3,6 days after randomization
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Percentage of Human Leukocyte Antigen-DR
Time Frame: 0,6 days after randomization
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Human Leukocyte Antigen-DR at 0, 6 days after randomization
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0,6 days after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qiu Haibo, Dr., Southeast university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 20, 2017
Primary Completion (ACTUAL)
July 28, 2019
Study Completion (ACTUAL)
January 8, 2020
Study Registration Dates
First Submitted
July 29, 2017
First Submitted That Met QC Criteria
August 2, 2017
First Posted (ACTUAL)
August 3, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 5, 2021
Last Update Submitted That Met QC Criteria
January 1, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017ZDSYLL025-P01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Mortality
IPD Sharing Time Frame
Study published
IPD Sharing Access Criteria
Supplyment
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Study Data/Documents
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Clinical Review& Education
Information identifier: 2Information 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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