The Role and Mechanism of Vimentin in Sepsis Patients

NCT03253146 | Unknown

• 1 other identifier: PUMCH ZS1080
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Vimentin; sepsis; immune cells; apoptosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

VIM detection DIAGNOSTIC_TEST

VIM expression in serum and lymphocytes detection

sepsis; septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Sepsis 3.0 was adopted to selected participants

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30952998 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Within 24 h (the first day of study) after ICU admission, blood samples was collected.Blood was centrifuged at 3,000 rpm for 15 minutes. The supernatants were transferred to Eppendorf tubes and stored at -80°C.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dawei Liu, MD

CONTACT

+86 10 69152305; dwliu98@126.com

Longxiang Su, MD

CONTACT

+86 10 69152300; slx77@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: July 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 17, 2017

Record last verified: 2016-05

Locations

CN (1)