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

NCT ID: NCT00498121

Last Updated: 2009-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Ventilator Associated Pneumonia

Keywords

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Ventilator associated pneumonia. Procalcitonin.

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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VAP patient

PROCALCITONIN LEVEL

Intervention Type DEVICE

measuring PROCALCITONIN LEVEL

Interventions

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PROCALCITONIN LEVEL

measuring PROCALCITONIN LEVEL

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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McGill University Health Center

Principal Investigators

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Salman A Qureshi, MD,FRCPSC

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

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McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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. doi: 10.1097/00000542-200201000-00018.

Reference Type BACKGROUND
PMID: 11753005 (View on PubMed)

Other Identifiers

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BMA-07-001 (mbasi100)

Identifier Type: -

Identifier Source: org_study_id