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

• ClinicalTrials.gov Identifier: NCT01847079
• Recruitment Status: Completed
• First Posted: May 6, 2013
• Last Update Posted: October 15, 2014
• Sponsor: Erasmus Medical Center
• Information provided by (Responsible Party): P.J. van der Geest, Erasmus Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infection	Other: Procalcitonin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1130 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Procalcitonin to Guide Obtaining Bloodcultures in the ICU. Intensive Care Infection Score.
• Study Start Date: January 2013
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Intervention group, procalcitonin; procalcitonin to guid obtaining bloodcultures in the ICU	Other: Procalcitonin; Procalcitonin to guide obtaining bloodcultures
No Intervention: Control group, ICIS, procalcitonin; Measurement of PCT and ICIS.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Netherlands

Erasmus MC

Rotterdam, Zuid Holland, Netherlands, 3015CE

Maasstad Ziekenhuis

Rotterdam, Zuid Holland, Netherlands, 3079DZ

Sponsors and Collaborators

Erasmus Medical Center

Investigators

• Principal Investigator: Patrick van der Geest, MD; Erasmus Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: P.J. van der Geest, MD, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT01847079
• Other Study ID Numbers: NL 38603.078.11
• First Posted: May 6, 2013
• Last Update Posted: October 15, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Infections; Communicable Diseases; Disease Attributes; Pathologic Processes