Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Infection

Clinical Trial Details

NCT number	NCT01847079
Study type	Interventional
Source	Erasmus Medical Center
Contact
Status	Completed
Phase	N/A
Start date	January 2013
Completion date	October 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score — ProBIC/ICIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms