CClinicalTrials.gg
Status unknownNCT03253146Updated Aug 17, 2017

The Role and Mechanism of Vimentin in Sepsis Patients

An observational study in Sepsis, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sepsis

Browse trials for

Keywords

  • Vimentin
  • sepsis
  • immune cells
  • apoptosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

Sepsis 3.0 was adopted to selected participants

Exclusion criteria

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.

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testVIM detection

    VIM expression in serum and lymphocytes detection

05

What researchers measure

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.

    Time frame: 28-day

06

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
07

References and documents

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. PubMed 30952998 ↗
08

Registry details

Key details

Study ID
NCT03253146
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Jul 1, 2016
Primary completion
Dec 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Aug 17, 2017

Study contacts

Dawei Liu, MD
Contact
dwliu98@126.com
+86 10 69152305
Longxiang Su, MD
Contact
slx77@163.com
+86 10 69152300

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion