Procalcitonin to guide obtaining bloodcultures in the ICU.

Completed

• Conditions: Bloodstream infection; sepsis.; 10019815

• Registration Number: NL-OMON39326
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1130

Inclusion Criteria

Patients will need to be over the age of 18, be suffering from an assumed infection deemed clinically worthy for blood culturing.

Exclusion Criteria

- Pregnancy.
- Neutropenia, defined as leukocyte count less then 0,5x10.000/L.
- Moribund patients.
- Predetermined illness with and expected death within 24 hours.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Safety, expressed as mortality at day 28 and 90, with a mortality difference<br /><br>not exceeding a between groups difference of 10% by<br /><br>non-inferiority analysis.<br /><br>2. Cost-effectiveness, expressed in euro, calculated by deducting costs of<br /><br>procalcitonine testing from saved blood cultures compared<br /><br>with standard treatment spending on blood cultures in the<br /><br>control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Length of stay on the ICU.<br /><br>2. Length of hospital stay.<br /><br>3. Positive predictive value (PPV), negative predictive value (NPV),<br /><br>sensitivity and specificity of procalcitonin for predicting microbial<br /><br>bloodstream infections. </p><br>