- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00726167
Serum Procalcitonin Study in the Management of Ventilated Patients
October 3, 2016 updated by: University of Missouri-Columbia
Clinical Utility of Serum Procalcitonin in the Management of Ventilator-Associated Pneumonia
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
mechanically ventilated surgical intensive care unit patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Once daily
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
antibiotic status (appropriateness, effectiveness, discontinuation criteria)
Time Frame: Once daily
|
Once daily
|
intubation date
Time Frame: Once daily
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Once daily
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microbiology data
Time Frame: Once daily
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Once daily
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PCT levels
Time Frame: Once daily
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Once daily
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pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts)
Time Frame: Once daily
|
Once daily
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jerry B Rogers, MD, University of Missouri-Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1164/rccm.200405-644ST. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
July 28, 2008
First Submitted That Met QC Criteria
July 28, 2008
First Posted (Estimate)
July 31, 2008
Study Record Updates
Last Update Posted (Estimate)
October 5, 2016
Last Update Submitted That Met QC Criteria
October 3, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1106537
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventilator Associated Pneumonia
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Hospital Alemão Oswaldo CruzMinistry of Health, BrazilRecruitingHealthcare-Associated Pneumonia | Ventilator-Associated Pneumonia | Healthcare Associated InfectionBrazil
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King Edward Memorial HospitalCompletedNosocomial Pneumonia | Healthcare-Associated Pneumonia | Aspiration Pneumonia | Ventilator-Associated PneumoniaIndia
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Cubist Pharmaceuticals LLCCompletedLung Diseases | Healthcare-Associated Pneumonia | Ventilator-Associated Pneumonia
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Arpida AGTerminatedHospital-Acquired Pneumonia | Ventilator-Associated Pneumonia | Health-Care-Associated Pneumonia
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University Hospital OlomoucCompletedVentilator-Associated Pneumonia
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Aydin Adnan Menderes UniversityNot yet recruitingVentilator-Associated PneumoniaTurkey
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Istanbul Medeniyet UniversityRecruiting
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University Hospital, ToulouseRecruitingVentilator-associated PneumoniaFrance
-
Erasmus Medical CenterChiesi Farmaceutici S.p.A.CompletedVentilator Associated Pneumonia (VAP)Spain, Netherlands
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Andrzej Frycz Modrzewski Krakow UniversityCompletedVAP - Ventilator Associated PneumoniaPoland
Clinical Trials on Procalcitonin Level
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CAMC Health SystemWithdrawnIntraventricular Hemorrhage | Intracerebral HemorrhageUnited States
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McGill University Health Centre/Research Institute...TerminatedVentilator Associated PneumoniaCanada
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Benha UniversityCompleted
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Centre Hospitalier Universitaire, AmiensCompleted
-
University of PittsburghNational Institute of General Medical Sciences (NIGMS); BioMérieuxCompletedLower Respiratory Tract Infection (LRTI)United States
-
Brahms FranceTerminated
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Kanuni Sultan Suleyman Training and Research HospitalCompletedWound Infection | Cesarean Wound DisruptionTurkey
-
Winthrop University HospitalCompletedPneumonia | Radiographic Lung InfiltratesUnited States
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Erasmus Medical CenterCompleted
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Centre Hospitalier Departemental VendeeTerminated