Predictive Value of Procalcitonin for Bacteremia in the ICU

June 18, 2024 updated by: Rijnstate Hospital
Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: Association of procalcitonin levels and blood cultures in critical illness patients on the ICU.

Objective: Procalcitonin is an acute phase protein. As part of the acute phase response, procalcitonin is produced during sepsis. Previous research shows that procalcitonin is a biomarker for bloodstream infection. However, there is still little known about the value of procalcitonin in diagnostics for micro-organism underlying a sepsis in ICU patients. In modern practice, blood cultures are taken when a patient is septic to determine the responsible micro-organism. When procalcitonin is a predictive value for bacteremia in the ICU, the number of blood cultures can be reduced.

Study design: An observational cohort study intervention: for each patient in the ICU blood cultures were taken, the procalcitonin level was determined. During 6 months 150 patients will be included.

Main study parameters/endpoints: this study will examine the predictive value of procalcitonin in blood cultures on the ICU.

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the ICU whom blood cultures are taken for suspected bacterial infection.

Description

Inclusion Criteria:

  • Patients admitted to the ICU
  • Age > 18 years

Exclusion Criteria:

  • Hemodialysis/ Continuous Veno-Venous Hemofiltration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The predictive value of procalcitonin in blood cultures on the ICU
Time Frame: 6 months

This study will examine the predictive value of procalcitonin on blood cultures on the ICU. A high value of procalcitonin is a predictor for bacteremia.

The predictive value: procalcitonin. Primary outcome: bacteremia .
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Study Chair: H.J. van Leeuwen, Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0877

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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