- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825357
Biological Markers to Identify Early Sepsis and Acute Lung Injury
January 26, 2016 updated by: Kuo-Chen Cheng, Chimei Medical Center
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tainan, Taiwan
- Department of Intensive Care Medicine; Chi Mei Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted to ICU and age ≧18-year-old.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The present study will focus on testing 'biological markers' to identify patients with sepsis and acute lung injury in early stage.
Time Frame: 72 hrs
|
72 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
January 15, 2009
First Submitted That Met QC Criteria
January 20, 2009
First Posted (Estimate)
January 21, 2009
Study Record Updates
Last Update Posted (Estimate)
January 28, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM-IRB09509002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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