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

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

    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital

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

  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.

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.
100ml Xuebijing Injection every 12 hours for 5 days
PLACEBO_COMPARATOR: Placebo group
normal saline 200 mL every 12 hours for 5 days
200ml normal saline every 12 hours for 5 days
Other Names:
  • NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 28 Days after randomization
Death from all causes at 28-days
28 Days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death in ICU
Time Frame: 28 Days after randomization
Death from all causes at ICU discharge
28 Days after randomization
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)
Day 0,3,6 after randomization
ICU stay
Time Frame: 28 days after randomization
Duration of stay in ICU
28 days after randomization
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
Day 0,3,6 after randomization
Duration of mechanical ventilation
Time Frame: 28 days after randomization
Duration of mechanical ventilation in ICU
28 days after randomization
Concentration of C-reactive protein
Time Frame: 0,3,6days after randomization
C-reactive protein at 0, 3,6 days after randomization
0,3,6days after randomization
Concentration of Procalcitonin
Time Frame: 0,3,6 days after randomization
Procalcitonin at 0,3,6days after randomization
0,3,6 days after randomization
Percentage of Human Leukocyte Antigen-DR
Time Frame: 0,6 days after randomization
Human Leukocyte Antigen-DR at 0, 6 days after randomization
0,6 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

  1. Clinical Review& Education
    Information identifier: 2
    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.

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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