Biological Markers to Identify Early Sepsis and Acute Lung Injury

Sponsor
Chimei Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00825357
Collaborator
(none)
30
1
59
0.5

Study Details

Study Description

Brief Summary

There are no clear markers to identify sepsis and acute lung injury at early stage in clinical settings which would result in improved survival of the patients. In collaboration with the research team led by Dr. Zhang at St. Michael's Hospital, Toronto, we have initiated a pilot study looking for biological markers to detect severe sepsis and ARDS. We have found that human neutrophils peptides (a-defensins), certain coagulation variables and cytokine levels are very sensitive markers to differentiate severe sepsis, ARDS from cardiovascular diseases in ICU patients. These findings may provide valuable information for therapeutic guideline in clinical practice. The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury. We will examine the roles of three components of markers including inflammation, neutrophil activation and coagulation. We are hoping that this proposed translational research will help develop novel therapeutic strategy in sepsis and acute lung injury patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Sep 1, 2006
    Actual Primary Completion Date :
    Aug 1, 2011
    Actual Study Completion Date :
    Aug 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury in early stage. [72 hrs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Meet diagnostic criteria of ≧2 SIRS or acute lung injury.

    • Get agreement of patient's attending physician and inform consent form patient or family.

    Exclusion Criteria:
    • Use Antibiotics over 24 hrs(only SIRS group).

    • Active bleeding.

    • Pregnancy.

    • Active Cancer (refer to malignancy which is recently diagnosed, under treatment, or relapsed)

    • VS or Subject or Family refuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Intensive Care Medicine; Chi Mei Medical Center Tainan Taiwan

    Sponsors and Collaborators

    • Chimei Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kuo-Chen Cheng, Chief, Chimei Medical Center
    ClinicalTrials.gov Identifier:
    NCT00825357
    Other Study ID Numbers:
    • CM-IRB09509002
    First Posted:
    Jan 21, 2009
    Last Update Posted:
    Jan 28, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Kuo-Chen Cheng, Chief, Chimei Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2016