Expired Study
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Columbia, Missouri 65212


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

1106537


NCT ID:

NCT00726167


Secondary ID:


Study Acronym:


Brief Title:

Serum Procalcitonin Study in the Management of Ventilated Patients


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Missouri-Columbia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

29


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jerry B Rogers, MD
Principal Investigator
University of Missouri-Columbia

Study Dates

Start Date:September 2008
Completion Date:August 2014
Completion Type:Actual
Primary Completion Date:August 2014
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 3, 2016
First Received Date:July 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts)
Time Frame:Once daily
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:PCT levels
Time Frame:Once daily
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:microbiology data
Time Frame:Once daily
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:intubation date
Time Frame:Once daily
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:antibiotic status (appropriateness, effectiveness, discontinuation criteria)
Time Frame:Once daily
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Procalcitonin Level
Description: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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Missouri-Columbia

Samples and Retentions

Study Population: mechanically ventilated surgical intensive care unit patients
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
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
Reference Type:Reference
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
Reference Type:Reference
Citation: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.
PMID:12627371
Reference Type:Reference
Citation:Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. Review.
PMID:11934711
Reference Type:Reference
Citation: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.
PMID:15699079
Reference Type:Reference
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.
PMID:15048056
Reference Type:Reference
Citation: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.
PMID:12475855
Reference Type:Reference
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.
PMID:11502658
Reference Type:Reference
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.
PMID:16208582
Reference Type:Reference
Citation:Christ-Crain M, Müller B. Procalcitonin and pneumonia: is it a useful marker? Curr Infect Dis Rep. 2007 May;9(3):233-40.
PMID:17430706
Reference Type:Reference
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.
PMID:12738607

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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