Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174122
Status:
UNKNOWN
Last Update Posted:
2006-03-01
First Post:
2005-09-13
Brief Title:
Procalcitonin in Diagnosing Bacteremia in the Emergency Department
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2004-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nowadays a physician plays a more important role in managing patients with potential infectious complications in the emergency room Previous studies demonstrated the importance of early and adequate anti-microbial therapy in reducing the mortality and morbidity of patients with severe sepsis However in one study about 6 of clinically significant bacteremic patients were misdiagnosed and discharged from the emergency room In other studies about 85 to approximately 17 of empirical antibiotic selection was judged inappropriately according to subsequent microbiology and anti-microbial susceptibility was a result It reflects the diversity in the presentations of infectious diseases and limited available microbiological reports from the first-line emergency physicians Timely diagnosis and selection of appropriate antibioticstreatment in treating those patients challenge an emergency physician more than ever before
A serum marker procalcitonin was recently demonstrated to be a potential indicator in distinguishing between non-infectious and infectious acute inflammatory reactions viral and bacterial infections and non-bacteremic and bacteremic infections It also demonstrates the association with high-mortality risk in patients with severe sepsis However some areas remain inconclusive in the clinical application of this potential serum marker
The investigators designed this prospective study with the following purposes
1 To clarify the sensitivity and specificity of the serum procalcitonin quantitative test as a clinical indicator of sepsis
2 To identify the cut-off value of the serum procalcitonin level in sepsis screening among various groups of patients with different co-morbidities
3 To test the potential role of the procalcitonin quantitative test in identifying occult sepsis in patients with an acute undifferentiated febrile reaction in the emergency room
4 To test the possibility of the sequential procalcitonin quantitative test as a serological guide of the appropriateness of an empirical antibiotic before the microbiology results are available
Conclusions in the investigators study will clarify the clinical application of the serum procalcitonin quantitative test in the differential diagnosis of patients with systemic inflammatory reaction syndrome the screening of high-risk sepsis patients and the effectiveness of an empirical antibiotic evaluation
A serum marker procalcitonin was recently demonstrated to be a potential indicator in distinguishing between non-infectious and infectious acute inflammatory reactions viral and bacterial infections and non-bacteremic and bacteremic infections It also demonstrates the association with high-mortality risk in patients with severe sepsis However some areas remain inconclusive in the clinical application of this potential serum marker
The investigators designed this prospective study with the following purposes
1 To clarify the sensitivity and specificity of the serum procalcitonin quantitative test as a clinical indicator of sepsis
2 To identify the cut-off value of the serum procalcitonin level in sepsis screening among various groups of patients with different co-morbidities
3 To test the potential role of the procalcitonin quantitative test in identifying occult sepsis in patients with an acute undifferentiated febrile reaction in the emergency room
4 To test the possibility of the sequential procalcitonin quantitative test as a serological guide of the appropriateness of an empirical antibiotic before the microbiology results are available
Conclusions in the investigators study will clarify the clinical application of the serum procalcitonin quantitative test in the differential diagnosis of patients with systemic inflammatory reaction syndrome the screening of high-risk sepsis patients and the effectiveness of an empirical antibiotic evaluation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None