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

This study has been terminated.
(One of the principal investigators has moved to a different institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498121
First Posted: July 9, 2007
Last Update Posted: December 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McGill University Health Center
  Purpose
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.

Condition Intervention
Ventilator Associated Pneumonia Device: PROCALCITONIN LEVEL

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Diagnostic and Prognostic Utility of Procalcitonin (ProCT) for Ventilator-associated Pneumonia (VAP)

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT [ Time Frame: Retrospective chart review after results are available ]

Estimated Enrollment: 50
Study Start Date: July 2007
Study Completion Date: May 2009
Groups/Cohorts Assigned Interventions
VAP patient Device: PROCALCITONIN LEVEL
measuring PROCALCITONIN LEVEL

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are intubated or more than 48 hours
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498121


Locations
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Salman A Qureshi, MD,FRCPSC McGill University Health Center
  More Information

Publications:
Responsible Party: McGill University Health Center
ClinicalTrials.gov Identifier: NCT00498121     History of Changes
Other Study ID Numbers: BMA-07-001 (mbasi100)
First Submitted: July 6, 2007
First Posted: July 9, 2007
Last Update Posted: December 18, 2009
Last Verified: December 2009

Keywords provided by McGill University Health Center:
Ventilator associated pneumonia.
Procalcitonin.

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs