Novel Biomarkers Related Xuebijing Injection Improves Sepsis

NCT06920420 | Not Yet Recruiting DMC

• 2 other identifiers: 2024ZDSYLL513-P0182472202
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.

  Single-cell transcriptomic analysis of inflammatory and metabolic gene expression, measured using scRNA-seq, with data summarized as differential expression profiles.

  Day7

Study Arms (3)

Xuebijing treatment group

Based on the standard treatment group Xuebijing injection was added.

Standard treatment group

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

Healthy Volunteer Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sepsis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Southeast University, China: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 9, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04