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Increase in Procalcitonin Kinetics May be a Good Indicator of Starting Empirical Antibiotic Treatment in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT02311816
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Domonkos Trásy, Szeged University

Brief Summary:
The value of procalcitonin change from the day before to the day when infection was suspected in predicting bacterial infection in intensive care patients.

Condition or disease
Bacterial Infection

Detailed Description:
Starting antibiotic therapy early in critically ill patients with suspected infection is of utmost importance with significant effect on survival. Procalcitonin is a reliable sepsis marker but results about its usefulness in initiating antimicrobials are conflicting. Our aim is to investigate the predictive value of 24 hours procalcitonin kinetics before starting empirical antibiotic therapy in intensive care patients as an indicator of the presence of bacterial infection.

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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Infection
Based on the microbiological results and clinical picture patients were grouped post hoc into "infection" and "no infection" groups by two independent experts (intensivist, infectologist) who were blinded for procalcitonin.
No infection
Based on the microbiological results and clinical picture patients were grouped post hoc into "infection" and "no infection" groups by two independent experts (intensivist, infectologist) who were blinded for procalcitonin.



Primary Outcome Measures :
  1. Procalcitonin kinetic [ Time Frame: 24 hours before starting empiric antibiotic treatment ]
    Procalcitonin levels are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.


Secondary Outcome Measures :
  1. C-reactive protein kinetic [ Time Frame: 24 hours before starting empiric antibiotic treatment ]
    C-reactive protein levels are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.

  2. Body temperature kinetic [ Time Frame: 24 hours before starting empiric antibiotic treatment ]
    Body temperatures are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.

  3. White blood cell count kinetic [ Time Frame: 24 hours before starting empiric antibiotic treatment ]
    White blood cell count levels are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with suspected infection during their stay on the intensive care unit were screened for eligibility. Patients were enrolled, when the attending intensive care specialist had a suspicion of infection and decided to start empirical antibiotic therapy and infalmmatory markers were available from the previous day.
Criteria

Inclusion Criteria:

  • Clinical signs of infection
  • Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
  • Microbiological sample sent for staining
  • Inflammatory markers available from the previous day

Exclusion Criteria:

  • Patients younger than 18 years
  • Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
  • Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment
  • Following cardiopulmonary resuscitation
  • End stage diseases with a "do not resuscitate" order
  • Immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy)
  • Post cardiac surgery patients

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): NCT02311816


Locations
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Hungary
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád, Hungary, H-6725
Sponsors and Collaborators
Domonkos Trásy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Domonkos Trásy, Ph.D. student; Department of Anaesthesiology and Intensive Therapy, Szeged University
ClinicalTrials.gov Identifier: NCT02311816     History of Changes
Other Study ID Numbers: PCT-infection
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Domonkos Trásy, Szeged University:
Bacterial infection, empiric antibiotic therapy

Additional relevant MeSH terms:
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Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents