Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score
Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score
NCT ID: NCT01847079 Phase: NA Status: COMPLETED Enrollment: 1130 Completion: 2014-10
Conditions
Infection
Interventions
Procalcitonin
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 aliq
Primary Outcome
- 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.