NCT00498121

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 18, 2009

Status Verified

December 1, 2009

First QC Date

July 6, 2007

Last Update Submit

December 17, 2009

Conditions

Keywords

Ventilator associated pneumonia.Procalcitonin.

Outcome Measures

Primary Outcomes (1)

  • Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT

    Retrospective chart review after results are available

Study Arms (1)

VAP patient

Device: PROCALCITONIN LEVEL

Interventions

measuring PROCALCITONIN LEVEL

VAP patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are intubated or more than 48 hours

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 11753005BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Salman A Qureshi, MD,FRCPSC

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

July 1, 2007

Study Completion

May 1, 2009

Last Updated

December 18, 2009

Record last verified: 2009-12

Locations