Clinical trial NCT01847079: Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score
Official title: Procalcitonin to Guide Obtaining Bloodcultures in the ICU. Intensive Care Infection Score.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 1130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Patrick van der Geest, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Geest PJ, Mohseni M, Nieboer D, Duran S, Groeneveld ABJ. Procalcitonin to guide taking blood cultures in the intensive care unit; a cluster-randomized controlled trial. Clin Microbiol Infect. 2017 Feb;23(2):86-91. doi: 10.1016/j.cmi.2016.10.004. Epub 2016 Oct 13.
citation: van der Geest PJ, Mohseni M, Linssen J, Duran S, de Jonge R, Groeneveld AB. The intensive care infection score - a novel marker for the prediction of infection and its severity. Crit Care. 2016 Jul 7;20(1):180. doi: 10.1186/s13054-016-1366-6.