The Role and Mechanism of Vimentin in Sepsis Patients

Sepsis Clinical Trial

Official title:

The Role and Mechanism of Vimentin in Sepsis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03253146
• Other study ID #: PUMCH ZS1080
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2017
• Last updated: August 15, 2017
• Start date: July 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2016
• Source: Peking Union Medical College Hospital
• Contact: Dawei Liu, MD
• Phone: +86 10 69152305
• Email: dwliu98[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sepsis is the most common cause of death in the clinical critically ill patients. We have successfully screened the sepsis biomarkers by clinical proteomics approach and found that Vimentin (VIM) played an important role in the occurrence and development of sepsis. However, the exact mechanism is remaining unclear. In this study, the relationship between the changes of peripheral circulation VIM expression and different stages of sepsis development will be further verified in lager clinical trials, as well as the relationship between VIM expression and apoptosis of immune cells (e.g lymphocytes) will also be clarified. This may indicate that the role of VIM in the cell-mediated immunity apoptosis and inflammation-related pathways. Through the implementation of this study, we can clarify the clinical value of VIM and the mechanism of VIM-mediated immune cell apoptosis during the sepsis development from the molecular level, and determine whether the VIM as a new target for sepsis diagnosis and treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Sepsis 3.0 was adopted to selected participants

Exclusion Criteria:

Participants were excluded if they were younger than 18 years of age; contracted acquired immunodeficiency syndrome; had reduced polymorphonuclear granulocyte counts (<500 µL-1); died within 24 h after admission to the ICU; refused to participate in the study; or declined treatment during the period of observation.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• VIM detection
VIM expression in serum and lymphocytes detection

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day survival	The survival time of patients more than 28days is defined as survival. The survival time of patients less than 28days is defined as death.	28-day