Procalcitonin Levels in Patients With Fever and a Central Line

NCT01175005 | Completed Results DMC

• 1 other identifier: PCH 10-042
• Study Type: observational
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fever

Keywords

Fever; Central venous catheter; Procalcitonin; Fever with a central venous catheter

Outcome Measures

Primary Outcomes (1)

• Procalcitonin Level at ED Presentation

  Level of procalcitonin will be obtained. At the end of the study we will determine who was septic or bacteremic and compare the procalcitonin levels between those who were septic/bacteremic and those who were not.We will attempt to identify whether a level of procalcitonin exists above which rates of bacteremia or bacterial sepsis in patients with fever and a central line exist. Blood cultures will be followed for up to 5 days until reported as final.There are no further study interventions.

  Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.

Study Arms (1)

Fever and a central venous catheter

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with fever and a central venous catheter who are 18 years of age and younger will be enrolled and will have PCT levels drawn in the Emergency Department.

You may qualify if:

• 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

You may not qualify if:

• Intravenous antibiotics in the 24 hours prior to presentation
• PICC line
• Parental refusal or inability to provide consent

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Related Publications (1)

• Kasem AJ, Bulloch B, Henry M, Shah K, Dalton H. Procalcitonin as a marker of bacteremia in children with fever and a central venous catheter presenting to the emergency department. Pediatr Emerg Care. 2012 Oct;28(10):1017-21. doi: 10.1097/PEC.0b013e31826caac2.

  PMID: 23023470 DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amanda Kasem
• Organization: Phoenixchildrens

akasem@phoenixchildrens.com

6025461910

Study Officials

• Amanda Kasem, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: August 4, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 30, 2011
• Results First Posted: April 27, 2011

Record last verified: 2011-05