NCT01847079

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,130 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
OTHER	Procalcitonin	Procalcitonin to guide obtaining bloodcultures

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-05-06
• Last updated: 2014-10-15

Locations

2 sites across 1 country: Netherlands