The Diagnostic and Prognostic Utility of Procalcitonin (P... | NCT00498121

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

NCT00498121

Sponsor

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

Status

Terminated

Last Update Posted

Dec 18, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Ventilator Associated Pneumonia

Interventions

PROCALCITONIN LEVEL

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

One of the principal investigators has moved to a different institution

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

May 2009Actual

First Submitted Date

Jul 6, 2007

First Submission Date that Met QC Criteria

Jul 6, 2007

First Posted Date

Jul 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2009

Last Update Posted Date

Dec 18, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
VAP patient			Device: PROCALCITONIN LEVEL

Name	Type	Description	Arm Group Labels	Other Names
PROCALCITONIN LEVEL	Device	measuring PROCALCITONIN LEVEL	VAP patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cases with VAP and high ProCT and Cases with Non-VAP and Low ProCT		Retrospective chart review after results are available

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who are intubated or more than 48 hours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salman A Qureshi, MD,FRCPSC	McGill University Health Centre/Research Institute of the McGill University Health Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McGill University Health Centre		Montreal	Quebec	H3A 1A1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11753005	Background	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.

ID	Term
D000077299	Healthcare-Associated Pneumonia
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia