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

Primary Purpose

Infection

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Procalcitonin
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus MC
  • Maasstad Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention group, procalcitonin

Control group, ICIS, procalcitonin

Arm Description

procalcitonin to guid obtaining bloodcultures in the ICU

Measurement of PCT and ICIS.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2013
Last Updated
October 13, 2014
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01847079
Brief Title
Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score
Acronym
ProBIC/ICIS
Official Title
Procalcitonin to Guide Obtaining Bloodcultures in the ICU. Intensive Care Infection Score.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group, procalcitonin
Arm Type
Other
Arm Description
procalcitonin to guid obtaining bloodcultures in the ICU
Arm Title
Control group, ICIS, procalcitonin
Arm Type
No Intervention
Arm Description
Measurement of PCT and ICIS.
Intervention Type
Other
Intervention Name(s)
Procalcitonin
Intervention Description
Procalcitonin to guide obtaining bloodcultures
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick van der Geest, MD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015CE
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3079DZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27746396
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.
Results Reference
derived
PubMed Identifier
27384242
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.
Results Reference
derived

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

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