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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00825357
Other study ID # CM-IRB09509002
Secondary ID
Status Completed
Phase N/A
First received January 15, 2009
Last updated January 26, 2016
Start date September 2006
Est. completion date August 2011

Study information

Verified date January 2016
Source Chimei Medical Center
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Department of Intensive Care Medicine; Chi Mei Medical Center Tainan

Sponsors (1)

Lead Sponsor Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury in early stage. 72 hrs No
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