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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:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00498121
First received: July 6, 2007
Last updated: December 17, 2009
Last verified: December 2009
History of Changes
  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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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)
Study First Received: July 6, 2007
Last Updated: December 17, 2009
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 23, 2013