The Efficacy of Xuebijing Injection on Sepsis

Sepsis Clinical Trial

Official title:

The Efficacy of Xuebijing Injection in Adult Patients With Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238742
• Other study ID #: 2017ZDSYLL025-P01
• Status: Completed
• Phase: Phase 4
• Start date: October 20, 2017
• Est. completion date: January 8, 2020

Study information

• Verified date: January 2021
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1817
• Est. completion date: January 8, 2020
• Est. primary completion date: July 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• Xuebijing Injection
100ml Xuebijing Injection every 12 hours for 5 days
• normal saline
200ml normal saline every 12 hours for 5 days

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	National Health and Family Planning Commission, P.R.China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Mortality	Death from all causes at 28-days	28 Days after randomization
Secondary	Death in ICU	Death from all causes at ICU discharge	28 Days after randomization
Secondary	SOFA score	Total Sequential Organ Failure Assessment (SOFA) score(0-24) ,higher values represent a worse outcome	Day 0,3,6 after randomization
Secondary	APACHE?	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
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation in ICU	28 days after randomization
Secondary	ICU stay	Duration of stay in ICU	28 days after randomization
Secondary	Concentration of C-reactive protein	C-reactive protein at 0, 3,6 days after randomization	0,3,6days after randomization
Secondary	Concentration of Procalcitonin	Procalcitonin at 0,3,6days after randomization	0,3,6 days after randomization
Secondary	Percentage of Human Leukocyte Antigen-DR	Human Leukocyte Antigen-DR at 0, 6 days after randomization	0,6 days after randomization