Novel Biomarkers Related Xuebijing Injection Improves Sepsis

NCT ID: NCT06920420

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-30

Study Completion Date

2028-12-31

Brief Summary

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Sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of ICU admission for critically ill patients, posing a serious threat to human health. The study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.

Detailed Description

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Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Xuebijing treatment group

Based on the standard treatment group Xuebijing injection was added.

No interventions assigned to this group

Standard treatment group

Patients with sepsis are given standard treatment according to international guidelines for the management of sepsis and septic shock

No interventions assigned to this group

Healthy Volunteer Group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Meeting the Sepsis 3.0 diagnostic criteria;
2. SOFA score ≥ 2 and \< 13;
3. Signed informed consent.

Exclusion Criteria

1. Age \<18 years or \>75 years;
2. Pregnant or lactating women;
3. Presence of severe primary diseases including malignant tumors severe hematologic disorders and HIV infection;
4. Current use of immunosuppressants or history of organ transplantation within the past 6 months;
5. Comorbidities that significantly affect vascular endothelial structure and function such as acute myocardial infarction.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Songqiao Liu

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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82472202

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024ZDSYLL513-P01

Identifier Type: -

Identifier Source: org_study_id

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