- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00976157
Serial Changes in sTREM-1 During Ventilator-associated Pneumonia (VAP)
September 14, 2009 updated by: Mackay Memorial Hospital
Serial Changes of Soluble TREM-1 Level in Bronchoalveolar Lavage Fluid During Ventilator-associated Pneumonia
Triggering receptor expressed on myeloid cells (TREM)-1 is a recently described molecule that plays an important role in myeloid cell-activated inflammatory responses.
The aim of this study was to investigate the evolutional change of soluble TREM-1 (sTREM-1) in bronchoalveolar lavage (BAL) fluid of clinically diagnosed ventilator-associated pneumonia (VAP) and its correlation with response to treatment and outcome.
Study Overview
Detailed Description
A prospective, interventional study conducted between August 2006 and August 2007 in MICU in Mackay Memorial Hospital, 35 patients with clinically diagnosed VAP were investigated.
sTREM-1 was measured in BAL samples using ELISA at the onset, 4th - 5th and 7th - 9th day of clinical diagnosis of VAP.Of these 35 patients, 27 had positive BAL culture.
The sTREM-1 levels in BAL fluid were measured and compared between patients with positive BAL culture and negative BAL culture.
Serial changes in sTREM-1 levels were evaluated in relation to patient outcome.
Study Type
Observational
Enrollment (Actual)
35
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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Taipei, Taiwan, 106
- Mackay Memorial Hospital
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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 to 86 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who were clinically suspected to have VAP were enrolled in the study.
VAP was clinically diagnosed with a new infiltrate on a chest radiograph in a patient receiving mechanical ventilation for more than 48 hr with at least one of the following: purulent tracheal secretions, a body temperature >38°C or <36°C, and leukocytosis (WBC > 10,000/mm³) or leukopenia (WBC < 4000/mm³)
Description
Inclusion Criteria:
- adult patients (older than 18 years)with clinically suspected VAP
Exclusion Criteria:
- mechanically ventilated patients post cardiopulmonary resuscitation
- patients with end stage diseases with life expectancy less than 3 months
- patients with solid or hematology transplantation
- patients on immunosuppressive agents
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Ventilator-associated pneumonia
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The bronchoscope was passed through endotracheal tube via a specific adaptor without topical anesthesia.
The bronchoscope was introduced and wedged into the segmental bronchial orifice where pneumonia was suspected.
Five aliquots of 20ml sterile saline were instilled and aspirated gently.
The first aliquot was discarded and the last 4 aliquots were pooled for analysis.
Part of the retrieved specimen in the first BAL fluid was sent to the laboratory immediately after collection for measurement of sTREM-1 level, the rest of sample was sent to microbiology lab for quantitative culture.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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mortality
Time Frame: 18 months
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18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chien Liang Wu, MD, Mackay Memorial Hospital, Taipei, Taiwan
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
August 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
September 11, 2009
First Submitted That Met QC Criteria
September 11, 2009
First Posted (Estimate)
September 14, 2009
Study Record Updates
Last Update Posted (Estimate)
September 15, 2009
Last Update Submitted That Met QC Criteria
September 14, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMH-I-S-201
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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