Serum Procalcitonin Study in the Management of Ventilated Patients

Ventilator Associated Pneumonia Clinical Trial

Official title:

Clinical Utility of Serum Procalcitonin in the Management of Ventilator-Associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726167
• Other study ID #: 1106537
• Status: Completed
• Phase: N/A
• First received: July 28, 2008
• Last updated: October 3, 2016
• Start date: September 2008
• Est. completion date: August 2014

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. Review. — View Citation

Christ-Crain M, Müller B. Procalcitonin and pneumonia: is it a useful marker? Curr Infect Dis Rep. 2007 May;9(3):233-40. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Once daily	No
Secondary	antibiotic status (appropriateness, effectiveness, discontinuation criteria)		Once daily	No
Secondary	intubation date		Once daily	No
Secondary	microbiology data		Once daily	No
Secondary	PCT levels		Once daily	No
Secondary	pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts)		Once daily	No