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NCT00976157 Clinical Trial

Serial Changes in sTREM-1 During Ventilator-associated Pneumonia (VAP)

Pneumonia Clinical Trial

Official title:
Serial Changes of Soluble TREM-1 Level in Bronchoalveolar Lavage Fluid During Ventilator-associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00976157
Other study ID # MMH-I-S-201
Secondary ID
Status Completed
Phase N/A
First received September 11, 2009
Last updated September 14, 2009
Start date August 2006
Est. completion date September 2008

Study information
Verified date September 2009
Source Mackay Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date September 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 86 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Bronchoscopy BAL
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.

Locations
Country Name City State
Taiwan Mackay Memorial Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality 18 months No
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