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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00726167
Other study ID # 1106537
Secondary ID
Status Completed
Phase N/A
First received July 28, 2008
Last updated October 3, 2016
Start date September 2008
Est. completion date August 2014

Study information

Verified date October 2016
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to test a new method for diagnosing and monitoring Ventilator-Associated Pneumonia, which is a major killer among ICU patients. The method requires analysis of a small amount of the patient's blood for concentration of a hormone called Procalcitonin.


Description:

Ventilator-associated pneumonia is a leading cause of mortality in critically ill patients. The purpose of this study is to evaluate the relationship between the onset/progress/resolution of pneumonia and the levels of Procalcitonin, a prohormone whose concentrations fluctuate in response to bacterial infection.


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Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Device:
Procalcitonin Level
Procalcitonin concentrations will be determined every day and will be compared with the clinical diagnosis based upon standard clinical practice. All subjects enrolled will be followed until the patient is either extubated or discharged from the SICU.

Locations

Country Name City State
United States University of Missouri Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of Procalcitonin concentration with the LungGuardian-derived Pneumonia Score in mechanically ventilated surgical intensive care unit patients. Using the data collected a positive and negative predictive value will be calculated. Once daily No
Secondary antibiotic status (appropriateness, effectiveness, discontinuation criteria) Once daily No
Secondary intubation date Once daily No
Secondary microbiology data Once daily No
Secondary PCT levels Once daily No
Secondary pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts) Once daily No
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