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The Efficacy of Xuebijing Injection on Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03238742
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
National Health and Family Planning Commission, P.R.China
Information provided by (Responsible Party):
Songqiao Liu, Southeast University, China

Study Description
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Brief Summary:
The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

Condition or disease Intervention/treatment Phase
Sepsis Drug: Xuebijing Injection Drug: normal saline Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1817 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Xuebijing Injection in Adult Patients With Sepsis
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : July 28, 2019
Actual Study Completion Date : January 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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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.
 Drug: Xuebijing Injection
100ml Xuebijing Injection every 12 hours for 5 days
Placebo Comparator: Placebo group
normal saline 200 mL every 12 hours for 5 days
 Drug: normal saline
200ml normal saline every 12 hours for 5 days
Other Name: NS


Outcome Measures
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Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 28 Days after randomization ]
    Death from all causes at 28-days


Secondary Outcome Measures :
  1. Death in ICU [ Time Frame: 28 Days after randomization ]
    Death from all causes at ICU discharge

  2. SOFA score [ Time Frame: Day 0,3,6 after randomization ]
    Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome

  3. APACHEⅡ [ Time Frame: Day 0,3,6 after randomization ]
    Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)

  4. Duration of mechanical ventilation [ Time Frame: 28 days after randomization ]
    Duration of mechanical ventilation in ICU

  5. ICU stay [ Time Frame: 28 days after randomization ]
    Duration of stay in ICU

  6. Concentration of C-reactive protein [ Time Frame: 0,3,6days after randomization ]
    C-reactive protein at 0, 3,6 days after randomization

  7. Concentration of Procalcitonin [ Time Frame: 0,3,6 days after randomization ]
    Procalcitonin at 0,3,6days after randomization

  8. Percentage of Human Leukocyte Antigen-DR [ Time Frame: 0，6 days after randomization ]
    Human Leukocyte Antigen-DR at 0, 6 days after randomization


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238742


Locations
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China, Jiangsu
Zhongda Hospital
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Southeast University, China
National Health and Family Planning Commission, P.R.China
Investigators
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Principal Investigator: Qiu Haibo, Dr. Southeast University
More Information
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Study Data/Documents: Clinical Review& Education  This link exits the ClinicalTrials.gov site
Identifier: 2
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Songqiao Liu, Principle investigator, Southeast University, China
ClinicalTrials.gov Identifier: NCT03238742    
Other Study ID Numbers: 2017ZDSYLL025-P01
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Mortality
Supporting Materials: Study Protocol
Time Frame: Study published
Access Criteria: Supplyment

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Songqiao Liu, Southeast University, China:
Xuebijing Injection, morality, sepsis
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes