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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847079
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
P.J. van der Geest, Erasmus Medical Center

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

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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

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.



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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847079


Locations
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Netherlands
Erasmus MC
Rotterdam, Zuid Holland, Netherlands, 3015CE
Maasstad Ziekenhuis
Rotterdam, Zuid Holland, Netherlands, 3079DZ
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Patrick van der Geest, MD Erasmus MC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Infection
Communicable Diseases