The Application of SERS and Metabolomics in Sepsis

NCT02213237 | Unknown DMC

• 1 other identifier: 201107031 RC
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

It has always been a real challenge to treat sepsis in critically ill patients. The mortality is as high as 20％ in patients with severe sepsis and 46％ with septic shock develops. Early diagnosis and early treatment are the principles. Along with appropriate resuscitation, judicious and thoughtful intravenous antibiotic therapy is the critical determinant of survival in sepsis and septic shock given that ineffective initial therapy worsens the outcome. Blood culture and subsequent susceptibility testing are the gold standard for microbiological diagnosis to direct the optimal use of antibiotic. However, this conventional approach usually takes 5-7 days to wait for the final report. Positive results were reported in only 30% of patients with sepsis and 50 to 60% septic shock. Moreover, the very low bacteria level in blood and prior use of antibiotics may prevent pathogen growth. Surface-enhanced Raman scattering (SERS) is a novel spectroscopy technique based on Raman scattering and localized surface plasma resonance (LSPR), which results in strongly enhanced Raman signals derived from molecules attached to nanometre-sized gold (Au) and silver (Ag) structures. SERS provides the structural information of biomedical molecules with ultra-sensitive characterization down to single molecular level in fast and non-destructive manner. The clinical application of SERS in sepsis will first help to recognize pathogens as well as their specific drug sensitivity, and then optimally guide the initial antibiotics usage. Plasma from twenty blood culture proven Gram positive, negative and Candida cases will separately subject to metabolomics profiling and bioinformatics analysis to establish each pathogen metabolites profile. The sensitivity and specificity of SERS and metabolomics in identifying pathogen and antibiotics-resistant strains will be evaluated. The investigators expected both techniques to play a crucial role in modern sepsis treatment and bring great impact on mortality reduction.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Identification of the causal pathogenic organism of sepsis subjects as well as the drug sensitivity test by SERS technique.

  By the SERS technique may measure one time as below: 1. Reducing detect/diagnosis time of bacteria or yeasts about blood sample of clinical sepsis subjects within one day. 2. Reducing detect/diagnosis time of bacteria or yeasts for the drug sensitivity test of sepsis subjects within one day.

  5-6 hours

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hospitalized patient with Septic shock

You may qualify if:

• \- Any hospitalized patient with
• Septic shock
• Before the use of parenteral or systemic antimicrobial therapy

You may not qualify if:

• Pregnant women
• Organ transplantation
• Cancer

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Yin-Yi Han, MD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Yin-Yi Han, MD

CONTACT

+886-9-72651405; Noviahan@gmail.com

Study Design

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

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: August 11, 2014
• Study Start: July 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

TW (1)