Sepsis-damaged Organs-double-markers Identification of Organ Failure Using Fluorescent Nanoparticle Tracking Analysis

NCT03222986 | Completed

• 1 other identifier: 04-XD37-104
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Systematic establishment of exosome proteomics in co-culture medium and clinical sepsis specimens will be done. Ubiquitination-autophagy-apoptosis biomarkers in exosomes will be detected and correlated to specific organ failure in sepsis. The inflammatory process also will be validated by cytokines analysis. NTA double markers identification will be a smart method to understand the exosome subpopulations.

Conditions

Sepsis With Multiple Organ Dysfunction (MOD)

Keywords

sepsis, nanoparticle tracking analysis

Outcome Measures

Primary Outcomes (1)

• Ubiquitination-autophagy-apoptosis biomarkers in exosomes will be detected and correlated to specific organ failure in sepsis

  Ubiquitination-autophagy-apoptosis biomarkers in exosomes will be detected and correlated to specific organ failure in sepsis

  within 24 hrs.

Secondary Outcomes (2)

• The inflammatory process also will be validated by cytokines analysis.

  within 24 hrs.

• NTA double markers identification will be a smart method to understand the exosome subpopulations.

  within 24 hrs.

Study Arms (2)

Sepsis with organ failure

Patients have organ failure

Sepsis without organ failure

Patients have no organ failure

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All included patients will be classified according to the sepsis-3 criteria, also treat according to surviving sepsis campaign guidelines. Every enrolled patients will be traced the infection sources with positive culture results. Enrolled septic patients will have an "acute change in total SOFA score ≥ 2 points consequent to infection"

You may qualify if:

• Septic patients will have an "acute change in total SOFA score ≥ 2 points consequent to infection" Sepsis with organ failure Sepsis without organ failure

You may not qualify if:

• patients who had chronic respiratory failure with ventilator dependence chronic renal failure with regular hemodialysis

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Wen-Lin Su

Taipei, Taiwan

Location

Related Publications (1)

• 1. Dombrovskiy, V.Y., et al., Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit Care Med, 2007. 35(5): p. 1244-50. 2. Angus, D.C., et al., Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med, 2001. 29(7): p. 1303-10. 3. Martin, G.S., et al., The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med, 2003. 348(16): p. 1546-54. 4. van Zanten, A.R., The golden hour of antibiotic administration in severe sepsis: avoid a false start striving for gold*. Crit Care Med, 2014. 42(8): p. 1931-2. 5. Duran-Bedolla, J., et al., Sepsis, mitochondrial failure and multiple organ dysfunction. Clin Invest Med, 2014. 37(2): p. E58-69.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Wen-Lin Su, PhD

  Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: July 1, 2017
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: February 4, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)