Pleural Fluid and Serum Procalcitonin in Patients With Parapneumonic Pleural Effusion
| Tracking Information | |||||
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| First Received Date ICMJE | March 25, 2008 | ||||
| Last Updated Date | February 27, 2013 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
treatment response [ Time Frame: 28 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00646490 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pleural Fluid and Serum Procalcitonin in Patients With Parapneumonic Pleural Effusion | ||||
| Official Title ICMJE | Diagnostic and Prognostic Values of Pleural Fluid Procalcitonin in Parapneumonic Pleural Effusion | ||||
| Brief Summary | Key words : serum, pleural effusion, procalcitonin, pneumonia Pneumonia is the common cause of pleural effusion (ranged 2nd) and bacterial infection is the main etiology of pneumonia. Procalcitonin, the prohormone of calcitonin, is a 116 amino-acid protein produced by C-cell of the thyroid gland. During severe infection, procalcitonin is probably produced by extra-thyroid tissues and the concentration increased rapidly in bacterial infection but remains low in viral infections. However, the exact origin and pathophysiological role of procalcitonin during sepsis is not clear and it is not a marker of infection as such, since localized infections or infections with no systemic manifestation cause a little if any increase in procalcitonin levels. This study will focus on assessing the value of procalcitonin in pleural effusion for diagnosis, severity and prognosis among community-acquired pneumonia with pleural effusion, such as in serum. 100 patients with clinical pneumonia infection score over six points diagnosed of community-acquired pneumonia and proved to have pleural effusion by chest sonography on admission will be studied prospectively. Serum and effusion procalcitonin levels will be measured initially and 3 days later after medical therapy. Bacterial pneumonia will be identified if bacteria was cultured from any one of the three kinds of specimen, including blood, pleural effusion or bronchoalveolar lavage. Then we will divide one hundred of patients into bacterial or non-bacterial groups. Finally, we will analyze demographic and procalcitonin data of serum and pleural effusion between these two groups and compare the difference between the severe or mild and response or non-response bacterial community-acquired pneumonia statistically. The aim of the study will be to verify whether procalcitonin levels measured in the serum and pleural effusion could serve as a predictor for bacterial community-acquired pneumonia with pleural effusion and the different levels will also be indicative of severity and prognosis. We hope that the predictor from pleural effusion will be more sensitive or specific than that from serum and could be detectable in localized bacterial infection. |
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| Detailed Description | In this study, the first goal will be to determine the sensitivity, specificity, and predictive value of serum and pleural effusion PCT level in CAP with pleural effusion. The second goal will be to decide an appropriate value in serum or pleural effusion to assess as an index of severity and prognosis in bacterial CAP with pleural effusion. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: serum,pleural fluid |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients from the out-patient-department in division of pulmonary and critical care medicine and the department of emergency medicine at Chang Gung Memorial Hospital, Kaohsiung. |
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| Condition ICMJE | Community Acquired Pneumonia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 17 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00646490 | ||||
| Other Study ID Numbers ICMJE | CMRPG840401 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Chang Gung Memorial Hospital | ||||
| Study Sponsor ICMJE | Chang Gung Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chang Gung Memorial Hospital | ||||
| Verification Date | March 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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