The Diagnostic and Prognostic Utility of Procalcitonin (ProCT) for Ventilator-Associated Pneumonia (VAP) - Full Text View

Sponsored by:	McGill University Health Center
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00498121

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

MedlinePlus related topics: Pneumonia

Drug Information available for: Procalcitonin

U.S. FDA Resources

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

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
Estimated Study Completion Date:	July 2008

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:

white blood cell count > 12 or < 5 x 10^9 cells/L,
temperature > 38°C or < 35°C, or
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:

Known underlying chronic inflammatory condition of the lung (e.g., sarcoidosis, vasculitis)
Thyroid cancer patients
neutropenia (neutrophils < 0.5 x 10^9 cells/L
Concomitant AIDS
Solid organ transplantation with severe immunosuppression
New Antibiotic use for more than 18 hrs before blood sample collection
Severe pancreatitis
Attending physician does not agree with enrollment into the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498121

Contacts

Contact: Salman A Qureshi, MD,FRCPSC	(514) 9341934 ext 44626	salman.qureshi@mcgill.ca
Contact: Mohammed B Alsaiari, MD,FRCPSC	(514) 4027747 ext -	mbasi100@hotmail.com

Locations

Canada, Quebec
McGill University Health Centre	Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Mohammed B Alsaiari, MD,FRCPSC (514) 4027747 ext - mbasi100@hotmail.com
Contact: Mohammed B Alsaiari, MD,FRCPSC (514) 4027747 ext - mbasi100@hotmail.com
Principal Investigator: Mohammed B Alsaiari, MD,FRCPSC

Sponsors and Collaborators

McGill University Health Center

Investigators

Principal Investigator:

Salman A Qureshi, MD,FRCPSC

McGill University Health Center

More Information

Publications:

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.

Responsible Party:	McGill University Health Center ( McGill University Health Center )
Study ID Numbers:	mbasi100
Study First Received:	July 6, 2007
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00498121
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.

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009