Procalcitonin to Guide Obtaining Bloodcultures in the ICU. Intensive Care Infection Score.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Erasmus Medical Center
- Enrollment
- 1,130
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group, ICIS, procalcitonin
Measurement of PCT and ICIS.
Intervention group, procalcitonin
procalcitonin to guid obtaining bloodcultures in the ICU
Intervention: Procalcitonin (Other)
Outcomes
Primary Outcomes
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.
Time Frame: 90 days
Secondary Outcomes
No secondary outcomes reported
Investigators
P.J. van der Geest
MD
Erasmus Medical Center