Serum Procalcitonin Study in the Management of Ventilated Patients

NCT ID: NCT00726167

Last Updated: 2016-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilator Associated Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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PCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerry B Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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Fartoukh M, Maitre B, Honore 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. doi: 10.1164/rccm.200212-1449OC. Epub 2003 May 8.

Reference Type BACKGROUND
PMID: 12738607 (View on PubMed)

Christ-Crain M, Muller B. Procalcitonin and pneumonia: is it a useful marker? Curr Infect Dis Rep. 2007 May;9(3):233-40. doi: 10.1007/s11908-007-0037-9.

Reference Type BACKGROUND
PMID: 17430706 (View on PubMed)

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. doi: 10.4414/smw.2005.11169.

Reference Type BACKGROUND
PMID: 16208582 (View on PubMed)

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. doi: 10.1378/chest.120.2.555.

Reference Type BACKGROUND
PMID: 11502658 (View on PubMed)

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. doi: 10.1378/chest.122.6.2115.

Reference Type BACKGROUND
PMID: 12475855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15048056 (View on PubMed)

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. doi: 10.1164/rccm.200405-644ST. No abstract available.

Reference Type BACKGROUND
PMID: 15699079 (View on PubMed)

Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.

Reference Type BACKGROUND
PMID: 11934711 (View on PubMed)

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. doi: 10.1086/368088. No abstract available.

Reference Type BACKGROUND
PMID: 12627371 (View on PubMed)

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 BACKGROUND

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 BACKGROUND

Other Identifiers

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1106537

Identifier Type: -

Identifier Source: org_study_id

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