N/A
N=62
Procalcitonin Levels in Patients With Fever and a Central Line
Fever
Bottom Line
View on ClinicalTrials.gov: NCT01175005 ↗Enrolled (actual)
62
Serious AEs
—
Results posted
Apr 2011
Primary outcome: Primary: Procalcitonin Level at ED Presentation — 18.47; 0.65 ng/dL — p=0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Phoenix Children's Hospital
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procalcitonin Level at ED Presentation |
18.47; 0.65 | 0.001 sig |
Summary
Procalcitonin (PCT) is one of many inflammatory markers which rises in response to infection. Many studies have shown this marker to be more indicative of a patient's clinical course in comparison to other inflammatory markers, such as Erythrocyte Sedimentation Rate (ESR) and C reactive protein (CRP), when assessing a patient's risk for serious infection. A particular population with potential for serious infection is that of the patient with fever and a central line, most often secondary to an oncologic disease. These patients are often neutropenic and unable to fight off infection, thereby rendering them extremely vulnerable to rapid declines in clinical status. By identifying a level of procalcitonin which is significant as a threshold for serious bacterial infection, the investigators can very early on identify the sickest patients and those who could potentially have a worse clinical course and/or outcome.
The primary study goal is to identify whether a level of procalcitonin exists above which rates of bacteremia or serious bacterial infections in patients with fever and a central line exist. The investigators will try to determine if levels of PCT correlate with bacterial infection in line sepsis in the specific population of patients who most often have a central line secondary to an oncologic process. The investigators proposed this theory since peak values of PCT have been shown to be elevated in acute settings making it a useful tool in this particular population.
Eligibility Criteria
Inclusion Criteria
- 18 years of age and younger
- Fever and a central venous catheter
- Presentation to an Emergency Department
- Central line secondary to Hematologic/Oncologic, Renal or Gastrointestinal disease
Exclusion Criteria
- Intravenous antibiotics in the 24 hours prior to presentation
- PICC line
- Parental refusal or inability to provide consent
Data sourced from ClinicalTrials.gov (NCT01175005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.