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

NCT ID: NCT01847079

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group, procalcitonin

procalcitonin to guid obtaining bloodcultures in the ICU

Group Type: OTHER

Procalcitonin

Intervention Type: OTHER

Procalcitonin to guide obtaining bloodcultures

Control group, ICIS, procalcitonin

Measurement of PCT and ICIS.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Procalcitonin

Procalcitonin to guide obtaining bloodcultures

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

P.J. van der Geest

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick van der Geest, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 27746396 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27384242 (View on PubMed)

Other Identifiers

NL 38603.078.11

Identifier Type: -

Identifier Source: org_study_id