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Serum Procalcitonin Study in the Management of Ventilated Patients

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ClinicalTrials.gov Identifier: NCT00726167
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
The purpose of this study is to test a new method for diagnosing and monitoring Ventilator-Associated Pneumonia, which is a major killer among ICU patients. The method requires analysis of a small amount of the patient's blood for concentration of a hormone called Procalcitonin.

Condition or disease Intervention/treatment
Ventilator Associated Pneumonia Device: Procalcitonin Level

Detailed Description:
Ventilator-associated pneumonia is a leading cause of mortality in critically ill patients. The purpose of this study is to evaluate the relationship between the onset/progress/resolution of pneumonia and the levels of Procalcitonin, a prohormone whose concentrations fluctuate in response to bacterial infection.

Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Utility of Serum Procalcitonin in the Management of Ventilator-Associated Pneumonia
Study Start Date : September 2008
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia


Intervention Details:
  • Device: Procalcitonin Level
    Procalcitonin concentrations will be determined every day and will be compared with the clinical diagnosis based upon standard clinical practice. All subjects enrolled will be followed until the patient is either extubated or discharged from the SICU.
    Other Name: PCT


Primary Outcome Measures :
  1. Correlation of Procalcitonin concentration with the LungGuardian-derived Pneumonia Score in mechanically ventilated surgical intensive care unit patients. Using the data collected a positive and negative predictive value will be calculated. [ Time Frame: Once daily ]

Secondary Outcome Measures :
  1. antibiotic status (appropriateness, effectiveness, discontinuation criteria) [ Time Frame: Once daily ]
  2. intubation date [ Time Frame: Once daily ]
  3. microbiology data [ Time Frame: Once daily ]
  4. PCT levels [ Time Frame: Once daily ]
  5. pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts) [ Time Frame: Once daily ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mechanically ventilated surgical intensive care unit patients
Criteria

Inclusion Criteria:

  • Are willing to give or who's proxy is willing to consent to be a study subject
  • Are at least 18 years of age;
  • Who are mechanically ventilated surgical intensive care unit patients.

Exclusion Criteria:

  • Participation in any investigational device or drug trial within 30 days prior to enrollment.

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): NCT00726167


Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Jerry B Rogers, MD University of Missouri-Columbia

Publications:
Mueller B and Prat C. Markers in acute inflammation in assessing and managing lower respiratory tract infections; focus on procalcitonin. Clin Microbiol Infect 2006; 12(Suppl):8-16
Phillips JO, Metzler MH, Huckfeldt RE, Keller ME, McBride CL. A Prospective evaluation of a simple disease management plan for nosocomial pneumonia in the ventilated trauma patient. Crit Care Med 1999: 27: 143

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00726167     History of Changes
Other Study ID Numbers: 1106537
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Ventilator associated Pneumonia
mechanically ventilated
procalcitonin
pneumonia scores

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