The Efficacy of Xuebijing Injection on Sepsis

Phase 4

Completed

• Conditions: Sepsis
• Interventions: Drug: normal saline; Drug: Xuebijing Injection

• Registration Number: NCT03238742
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study First Submitted: 2017-07-29
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-03
• Study Start: 2017-10-20
• Primary Completion: 2019-07-28
• Study Completion: 2020-01-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-01
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1817

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	normal saline	normal saline 200 mL every 12 hours for 5 days
Intervention Group	Xuebijing Injection	100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	28 Days after randomization	Death from all causes at 28-days

Secondary Outcome Measures

Name	Time	Method
SOFA score	Day 0,3,6 after randomization	Total Sequential Organ Failure Assessment (SOFA) score(0-24) ，higher values represent a worse outcome
Percentage of Human Leukocyte Antigen-DR	0，6 days after randomization	Human Leukocyte Antigen-DR at 0, 6 days after randomization
Death in ICU	28 Days after randomization	Death from all causes at ICU discharge
Duration of mechanical ventilation	28 days after randomization	Duration of mechanical ventilation in ICU
ICU stay	28 days after randomization	Duration of stay in ICU
Concentration of C-reactive protein	0,3,6days after randomization	C-reactive protein at 0, 3,6 days after randomization
APACHEⅡ	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)
Concentration of Procalcitonin	0,3,6 days after randomization	Procalcitonin at 0,3,6days after randomization

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China