The Role and Mechanism of Vimentin in Sepsis Patients

NCT ID: NCT03253146

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2017-12-31

Brief 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.

Conditions

Sepsis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

sepsis

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.

Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.

The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction.

ASOFA score ≥2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection. Even patients presenting with modest dysfunction can deteriorate further, emphasizing the seriousness of this condition and the need for prompt and appropriate intervention, if not already being instituted.

In lay terms, sepsis is a life-threatening condition that arises when the body's response to an infection injures its own tissues and organs.

VIM detection

Intervention Type: DIAGNOSTIC_TEST

VIM expression in serum and lymphocytes detection

septic shock

Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L (18mg/dL) despite adequate volume resuscitation.

VIM detection

Intervention Type: DIAGNOSTIC_TEST

VIM expression in serum and lymphocytes detection

Interventions

VIM detection

VIM expression in serum and lymphocytes detection

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dawei Liu, MD

Role: CONTACT

dwliu98@126.com

+86 10 69152305

Longxiang Su, MD

Role: CONTACT

slx77@163.com

+86 10 69152300

Facility Contacts

Dawei Liu, MD

Role: primary

dwliu98@126.com

+86 10 69152305

References

Su L, Pan P, Yan P, Long Y, Zhou X, Wang X, Zhou R, Wen B, Xie L, Liu D. Role of vimentin in modulating immune cell apoptosis and inflammatory responses in sepsis. Sci Rep. 2019 Apr 5;9(1):5747. doi: 10.1038/s41598-019-42287-7.

Reference Type: DERIVED

PMID: 30952998 (View on PubMed)

Other Identifiers

PUMCH ZS1080

Identifier Type: -

Identifier Source: org_study_id