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

Terminated

• Conditions: Ventilator Associated Pneumonia
• Interventions: Device: PROCALCITONIN LEVEL

• Registration Number: NCT00498121
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-06
• Study First Submitted QC: 2007-07-06
• Study First Posted: 2007-07-09
• Study Completion: 2009-05
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VAP patient	PROCALCITONIN LEVEL	-

Primary Outcome Measures

Name	Time	Method
Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT	Retrospective chart review after results are available

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada