The Diagnostic and Prognostic Utility of Procalcitonin (ProCT) for Ventilator-associated Pneumonia (VAP)

Ventilator Associated Pneumonia Clinical Trial

Official title:

The Diagnostic and Prognostic Utility of Procalcitonin (ProCT) for Ventilator-associated Pneumonia (VAP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00498121
• Other study ID #: BMA-07-001 (mbasi100)
• 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
• 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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

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