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

NCT01847079 | Completed DMC

• 1 other identifier: NL 38603.078.11
• Study Type: interventional
• Target: 1,130
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (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.

  90 days

Study Arms (2)

Intervention group, procalcitonin

OTHER

procalcitonin to guid obtaining bloodcultures in the ICU

Other: Procalcitonin

Control group, ICIS, procalcitonin

NO INTERVENTION

Measurement of PCT and ICIS.

Interventions

Procalcitonin OTHER

Procalcitonin to guide obtaining bloodcultures

Intervention group, procalcitonin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will need to be over the age of 18 and suffering from an assumed infection deemed clinically worthy for blood culturing.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (2)

Erasmus MC

Rotterdam, South Holland, 3015CE, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079DZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 27746396 DERIVED

• 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.

  PMID: 27384242 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Procalcitonin

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Officials

• Patrick van der Geest, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 6, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

NL (2)