Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score

Study Overview
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Brief Summary
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PROBIC Rationale: Procalcitonin measurements can reduce the number of blood cultures in the ICU. Objective: The investigators suggest that PCT is a marker for blood stream infection in all patients in the ICU in whom attending physicians/ intensivists order blood culturing in the suspicion of microbial infection. The investigators want to demonstrate that its use for guiding blood culturing is cost-effective and safe compared with blood cultures alone. Study design: Prospective, non- inferiority, multicenter, single-blinded, cluster- randomised cross-over clinical trial. Intervention (if applicable): The intensive care units will be allocated into two groups: a control group (blood culture) and the intervention group (procalcitonin). Main study parameters/endpoints: Safety, expressed as mortality at day 28 and 90, with a mortality difference not exceeding a between groups difference of 10% by non-inferiority analysis. Cost-effectiveness, expressed in euro, calculated by deducting costs of procalcitonin testing from saved blood cultures compared with standard treatment spending on blood cultures in the control group. ICIS Rationale: The aim was to evaluate the Intensive Care Infection Score (ICIS) in predicting microbial infection and its sequelae in critically ill patients in whom attending physicians/ intensivists order blood culturing in the suspicion of microbial infection. Objective: Because of the complexity of the pathophysiology of systemic inflammation it is unlikely that a single parameter will have sufficient diagnostic accuracy for infection. Therefore we will study combining parameters producing a diagnostic score. Study design: Prospective, multicenter, cohort trial. Supplement for the control arm of the ProBIC study. Intervention (if applicable): Blood is drawn for daily routine laboratory measurements and collected in K3EDTA aliqnots. The ICIS score is composed of five blood-cell derived parameters which can be extracted using the same aliqnots. Main study parameters/endpoints: To develop and evaluate a blood- cell derived score to enable the diagnosis of microbial infection, its likelihood, its invasiveness and severity.

Official Title
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Procalcitonin to Guide Obtaining Bloodcultures in the ICU. Intensive Care Infection Score.

Conditions
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Infection

Intervention / Treatment
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* Other: Procalcitonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will need to be over the age of 18 and suffering from an assumed infection deemed clinically worthy for blood culturing. Exclusion Criteria: Uncontrolled malignancy Immunosuppressive or immunostimulatory therapy Neutropenia, defined as leukocyte count less then 0.5x109/L Moribund patients Predetermined illness with an expected death within 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group, procalcitonin<br>procalcitonin to guid obtaining bloodcultures in the ICU | Other: Procalcitonin<br>* Procalcitonin to guide obtaining bloodcultures<br>|
| No Intervention: Control group, ICIS, procalcitonin<br>Measurement of PCT and ICIS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Safety, expressed as mortality at day 28 and 90, with a mortality difference not exceeding a between groups difference of 10% by non-inferiority analysis. |  | 90 days |