Expression of TIM-3 on Lymphocytes in Sepsis

Sepsis Clinical Trial

Official title:

Expression and the Clinical Significance of TIM-3 on Lymphocytes During Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02319876
• Other study ID #: TIM3-SEPSIS
• Secondary ID: 81201492
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2014
• Last updated: July 27, 2015
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Changhai Hospital
• Contact: Lulong Bo, M.D., Ph.D.
• Phone: +862131163489
• Email: lulongbo[@]gmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.

Description:

Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with severe sepsis

• patients undergo invasive spine surgery

• healthy volunteers

Exclusion Criteria:

• patients with immunodeficient diseases

• patients who accept glucocorticoid or immunosuppressant

• patients with an age older than 18 years

• patients providing the informed consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immunosuppression
• Sepsis

Locations

Country	Name	City	State
China	Anesthesiology and Intensive Care, Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes	TIM-3 level on T cells was compared between different populations.	within 24h after recruitment	No
Secondary	28-day mortality		28 days after diagnosis of sepsis	No