Pleural Fluid and Serum Procalcitonin in Patients With Parapneumonic Pleural Effusion

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00646490
Collaborator
(none)
150
1
48
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic and Prognostic Values of Pleural Fluid Procalcitonin in Parapneumonic Pleural Effusion
    Study Start Date :
    Jul 1, 2005
    Actual Primary Completion Date :
    Jul 1, 2009
    Actual Study Completion Date :
    Jul 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    A

    patients with parapneumonic pleural effusion due to community acquired pneumonia

    B

    patients with pleural effusion of other etiologies

    Outcome Measures

    Primary Outcome Measures

    1. treatment response [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • A consecutive series of patients (17 years or older) who present to our hospital with suspected CAP with pleural effusion in the planning duration will be studied. All study cases had not received systemic or topical antimicrobial therapy during the 3 days before the study and they had never smoked at least one cigarette per day for 1 year. A case will be enrolled subsequently by the diagnosis of CAP with pleural effusion from clinical pneumonia infection score (CPIS) and chest sonography.
    Exclusion Criteria:
    • Patients with known thyroid disease or small cell lung cancer will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang Gung Memorial Hospital, Kaohsiung Kaohsiung Taiwan 833

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    • Study Chair: Meng-Chih Lin, MD, Chang Gung Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT00646490
    Other Study ID Numbers:
    • CMRPG840401
    First Posted:
    Mar 28, 2008
    Last Update Posted:
    Feb 28, 2013
    Last Verified:
    Mar 1, 2008
    Keywords provided by Chang Gung Memorial Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2013