Serum Procalcitonin Study in the Management of Ventilated Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00726167
First received: July 28, 2008
Last updated: December 8, 2008
Last verified: December 2008
  Purpose

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 Intervention
Ventilator Associated Pneumonia
Device: Procalcitonin Level

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Utility of Serum Procalcitonin in the Management of Ventilator-Associated Pneumonia

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • antibiotic status (appropriateness, effectiveness, discontinuation criteria) [ Time Frame: Once daily ] [ Designated as safety issue: No ]
  • intubation date [ Time Frame: Once daily ] [ Designated as safety issue: No ]
  • microbiology data [ Time Frame: Once daily ] [ Designated as safety issue: No ]
  • PCT levels [ Time Frame: Once daily ] [ Designated as safety issue: No ]
  • pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts) [ Time Frame: Once daily ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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
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.

  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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726167

Contacts
Contact: Tara M Powell, ASN, RN 573-882-4976 powelltm@health.missouri.edu
Contact: Jerry B Rogers, MD (573) 882-1379 rogersjb@health.missouri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Tara M Powell, ASN         
Contact: Jerry B Rogers, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Jerry B Rogers, MD University of Missouri-Columbia
  More Information

Publications:
Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med 2002; 165:867-903
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: Dr. Jerry B. Rogers, University of Missouri
ClinicalTrials.gov Identifier: NCT00726167     History of Changes
Other Study ID Numbers: 1106537
Study First Received: July 28, 2008
Last Updated: December 8, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014