Serum Procalcitonin Study in the Management of Ventilated Patients - Full Text View

Sponsored by:	University of Missouri-Columbia
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00726167

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

MedlinePlus related topics: Pneumonia

Drug Information available for: Procalcitonin

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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:

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.

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

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:

Fartoukh M, Maitre B, Honoré S, Cerf C, Zahar JR, Brun-Buisson C. Diagnosing pneumonia during mechanical ventilation: the clinical pulmonary infection score revisited. Am J Respir Crit Care Med. 2003 Jul 15;168(2):173-9. Epub 2003 May 8.

Christ-Crain M, Müller B. Procalcitonin and Pneumonia: Is it a Useful Marker? Curr Infect Dis Rep. 2007 May;9(3):233-40.

Christ-Crain M, Muller B. Procalcitonin in bacterial infections--hype, hope, more or less? Swiss Med Wkly. 2005 Aug 6;135(31-32):451-60. Review.

Ibrahim EH, Tracy L, Hill C, Fraser VJ, Kollef MH. The occurrence of ventilator-associated pneumonia in a community hospital: risk factors and clinical outcomes. Chest. 2001 Aug;120(2):555-61.

Rello J, Ollendorf DA, Oster G, Vera-Llonch M, Bellm L, Redman R, Kollef MH; VAP Outcomes Scientific Advisory Group. Epidemiology and outcomes of ventilator-associated pneumonia in a large US database. Chest. 2002 Dec;122(6):2115-21.

Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R; CDC; Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-care--associated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep. 2004 Mar 26;53(RR-3):1-36.

American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. No abstract available.

Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med 2002; 165:867-903

Nylen E, Muller B, Becker KL, Snider R. The future diagnostic role of procalcitonin levels: the need for improved sensitivity. Clin Infect Dis. 2003 Mar 15;36(6):823-4; author reply 826-7. No abstract available.

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 ( Dr. Jerry B. Rogers )
Study ID Numbers:	1106537
Study First Received:	July 28, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00726167
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:

Ventilator associated Pneumonia
mechanically ventilated
procalcitonin
pneumonia scores

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 14, 2009