The Role and Mechanism of Vimentin in Sepsis Patients

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: VIM detection

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Dawei Liu, MD; Phone Number: +86 10 69152305; Email: dwliu98@126.com
• Study Contact Backup: Name: Longxiang Su, MD; Phone Number: +86 10 69152300; Email: slx77@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Dawei Liu, MD; Phone Number: +86 10 69152305; Email: dwliu98@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Between july 2016 and december 2017, inpatients were included who were in the Department of critical care medicine of the Peking Union Medical College Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: VIM detection; 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.	Diagnostic test: VIM detection; VIM expression in serum and lymphocytes detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: sepsis; apoptosis; immune cells; Vimentin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: PUMCH ZS1080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No