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NCT Number: NCT03238742

The Efficacy of Xuebijing Injection on Sepsis

The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xuebijing Injection

Drug

100ml Xuebijing Injection every 12 hours for 5 days

normal saline

Drug

200ml normal saline every 12 hours for 5 days

Other names: NS

Primary outcomes

  1. All-Cause Mortality

    Time frame: 28 Days after randomization

    Death from all causes at 28-days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Collaborators

  • National Health and Family Planning Commission, P.R.China

Registry information

Official study title

The Efficacy of Xuebijing Injection in Adult Patients With Sepsis

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 3, 2017
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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