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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00498121
Other study ID # BMA-07-001 (mbasi100)
Secondary ID
Status Terminated
Phase N/A
First received July 6, 2007
Last updated December 17, 2009
Start date July 2007
Est. completion date May 2009

Study information

Verified date December 2009
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health Canada
Study type Observational

Clinical Trial Summary

Our aim in this study is to investigate the potential role of serum ProCT as an early diagnostic marker and later prognostic indicator for VAP.


Description:

Ventilator-associated pneumonia (VAP), a bacterial infection that develops after 48 hours or more of intubation, is associated with high morbidity and mortality. Rapid identification of VAP is required to improve survival and to reduce avoidable treatment-associated side effects. Procalcitonin (ProCT), a blood test, is a reasonably specific marker of bacterial infection and its level increases early in sepsis. In this study, a ProCT serum level will be measured in 50 patients with clinically suspected VAP. We aim to show that the ProCT level will be high early in VAP and will stay high in patients with poor prognosis. This will help to address the potential role of ProCT as part of early diagnosis and management of VAP.


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date May 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

In the preceding 24 h, the appearance of a new opacity or opacities on chest X-ray when compared to previous, and two of the following:

1. white blood cell count > 12 or < 5 x 10^9 cells/L,

2. temperature > 38°C or < 35°C, or

3. purulent secretions.endotracheal samples must be collected by bronchoscope/bronchoalveolar lavage with quantitative culture or endotracheal aspiration with quantitative culture (when available) or qualitative culture from each patient to be enrolled in the study. This is a routine procedure done in every case of suspected VAP and is considered to be the standard of care.

Exclusion Criteria:

1. Known underlying chronic inflammatory condition of the lung (e.g., sarcoidosis, vasculitis)

2. Thyroid cancer patients

3. neutropenia (neutrophils < 0.5 x 10^9 cells/L

4. Concomitant AIDS

5. Solid organ transplantation with severe immunosuppression

6. New Antibiotic use for more than 18 hrs before blood sample collection

7. Severe pancreatitis

8. Attending physician does not agree with enrollment into the study.

Study Design

Time Perspective: Prospective


Intervention

Device:
PROCALCITONIN LEVEL
measuring PROCALCITONIN LEVEL

Locations

Country Name City State
Canada McGill University Health Centre Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Duflo F, Debon R, Monneret G, Bienvenu J, Chassard D, Allaouchiche B. Alveolar and serum procalcitonin: diagnostic and prognostic value in ventilator-associated pneumonia. Anesthesiology. 2002 Jan;96(1):74-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT Retrospective chart review after results are available No
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