Serum Procalcitonin Study in the Management of Ventilated Patients
Sponsor
University of Missouri-Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT00726167
Collaborator
(none)
29
1
71
0.4
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
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
:
Sep 1, 2008
Actual Primary Completion Date
:
Aug 1, 2014
Actual Study Completion Date
:
Aug 1, 2014
Outcome Measures
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. [Once daily]
Secondary Outcome Measures
- antibiotic status (appropriateness, effectiveness, discontinuation criteria) [Once daily]
- intubation date [Once daily]
- microbiology data [Once daily]
- PCT levels [Once daily]
- pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts) [Once daily]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. Review.
- 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, Müller B. Procalcitonin in bacterial infections--hype, hope, more or less? Swiss Med Wkly. 2005 Aug 6;135(31-32):451-60. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00726167
Other Study ID Numbers:
- 1106537
First Posted:
Jul 31, 2008
Last Update Posted:
Oct 5, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Missouri-Columbia
Additional relevant MeSH terms: