Procalcitonin Levels in Patients With Fever and a Central Line

This study has been completed.
Sponsor:
Information provided by:
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01175005
First received: July 28, 2010
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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.


Condition
Fever

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin as a Marker of Serious Infection in Patients With Fever and a Central Venous Catheter

Resource links provided by NLM:


Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:
  • Procalcitonin Level at ED Presentation [ Time Frame: Initial blood draw in ED and if admitted a second level will be obtained at 24 hours. ] [ Designated as safety issue: No ]
    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.


Enrollment: 62
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fever and a central venous catheter

Detailed Description:

A prospective study in which patients presenting to the Emergency Department (ED) with fever and a central line will have procalcitonin levels checked, along with their CBC and blood culture. Procalcitonin levels will be recorded and blood culture results will be followed to see whether higher procalcitonin levels correlate with a greater risk of having a positive blood culture.

A prospective study will be conducted on patients with fever and a central line who present to the Emergency Department. Written informed consent will be obtained for each patient. We will include all patients 18 years of age and younger and exclude patients who had received antibiotics within the previous 24 hours of presenting to the ED as studies have shown that PCT levels dramatically decrease with the institution of antibiotic therapy. Patients will be identified on presentation to our ED with a chief complaint of "Fever and Central Venous Catheter". Diagnosis of sepsis will be made by clinical findings (fever, chills, altered mental status…) and confirmed by laboratory findings (leukocytosis or leucopenia with neutropenia, and later positive blood cultures). Management of each individual patient was determined by the pediatric emergency medicine physician in consult with a pediatric hematologist-oncologist and, in required cases, by an intensivist.

On presentation to the ED, all patients will have a CBC with differential, blood culture from the central line and procalcitonin levels drawn. All will receive empiric antibiotics initiated with either Ceftriaxone (if the patients is clinically stable and non-neutropenic defined as an Absolute Neutrophil Count (ANC)>1500 cells/microliter) or with Cefepime and Gentamicin in the neutropenic or ill appearing patient.

Electronic medical records will be reviewed for patient demographics, medical and social history and clinical presentation. Medical records during admission will be used to follow the progression and hospital stay as well as the management used. Office records will be used for post admission outcomes.

Levels of PCT will be determined using the Brahms Kryptor compact which required a minimum of 200 microliters of plasma, serum or whole blood to run a PCT level and could detect a level as low as <0.02ng/ml within 20-25 minutes. Levels reported as <0.05ng/ml are considered not indicative of sepsis while levels >2 ng/ml are indicative of high sepsis probability. Levels in between 0.05 and 2 suggest a repeat level be drawn after 24 hours.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175005

Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: Amanda Kasem, MD Phoenix Children's Hospital
  More Information

No publications provided by Phoenix Children's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amanda Kasem, MD Principal Investigator, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01175005     History of Changes
Other Study ID Numbers: PCH 10-042
Study First Received: July 28, 2010
Results First Received: March 29, 2011
Last Updated: May 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:
Fever
Central venous catheter
Procalcitonin
Fever with a central venous catheter

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014