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Trial Outcomes & Findings for Procalcitonin Levels in Patients With Fever and a Central Line (NCT NCT01175005)

NCT ID: NCT01175005

Last Updated: 2011-05-30

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

62 participants

Primary outcome timeframe

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

Results posted on

2011-05-30

Participant Flow

Participant milestones

Participant milestones
Measure
Fever and a Central Venous Catheter
Overall Study
STARTED
62
Overall Study
COMPLETED
62
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Procalcitonin Levels in Patients With Fever and a Central Line

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fever and a Central Venous Catheter
n=62 Participants
Age, Categorical
<=18 years
62 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Age Continuous
6 years
STANDARD_DEVIATION 4.8 • n=93 Participants
Sex: Female, Male
Female
26 Participants
n=93 Participants
Sex: Female, Male
Male
36 Participants
n=93 Participants
Region of Enrollment
United States
62 participants
n=93 Participants
Neutropenic
neutropenic
27 participants
n=93 Participants
Neutropenic
Non neutropenic
35 participants
n=93 Participants
Blood culture
Blood culture negative
48 participants
n=93 Participants
Blood culture
Blood culture positive
14 participants
n=93 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Blood Culture Positive
n=14 Participants
Procalcitonin level in patients with fever and a CVC with positive blood culture
Blood Culture Negative
n=48 Participants
Procalcitonin level in patients with fever and a CVC with negative blood culture
Procalcitonin Level at ED Presentation
18.47 ng/dL
Interval 17.42 to 19.52
0.65 ng/dL
Interval 0.08 to 1.22

Adverse Events

Fever and a Central Venous Catheter

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Kasem

Phoenixchildrens

Phone: 6025461910

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place