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Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT02294695
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Domonkos Trásy, Szeged University

Brief Summary:
To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after starting empirical antibiotic therapy in critically ill patients, to predict appropriate or inappropriate antibiotic treatment.

Condition or disease
Bacterial Infections

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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Early Procalcitonin Kinetics May Indicate Effectiveness of the Empirical Antibiotic Therapy in Sepsis Within Hours
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

MedlinePlus related topics: Antibiotics

Group/Cohort
Appropriate empiric antibiotic therapy
Based on the microbiological results patients were grouped post hoc into "appropriate" and "inappropriate" groups by two independent experts (intensivist, infectologist) who were blinded for PCT.
Inappropriate empiric antibiotic therapy
Based on the microbiological results patients were grouped post hoc into "appropriate" and "inappropriate" groups by two independent experts (intensivist, infectologist) who were blinded for PCT.



Primary Outcome Measures :
  1. Procalcitonin kinetic [ Time Frame: The first six days after starting empiric antibiotic treatment ]
    PCT levers are measured every 8 hours in the first day after starting empiric antibiotic treatment then daily and the changes in percentage are followed form the baseline value measured right before the first exposition of the antibiotic therapy.


Secondary Outcome Measures :
  1. Sequential Organ Failure Assessment score [ Time Frame: The first six days after starting empiric antibiotic treatment ]
    SOFA score is measured every day after starting empiric antibiotic treatment.


Other Outcome Measures:
  1. Length of Intensive Care Unit stay [ Time Frame: Maximum 90 days after enrollment ]
  2. Intensive Care Unit mortality [ Time Frame: Maximum 90 days after enrollment ]
  3. Length of hospital stay [ Time Frame: Maximum 90 days after enrollment ]
  4. Hospital mortality [ Time Frame: Maximum 90 days after enrollment ]


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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 over 18 years with suspected infection on admission or 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.
Criteria

Inclusion Criteria:

  • Clinical signs of infection
  • Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
  • Suspected site of infection has to be present and documented
  • Microbiological sample sent for staining
  • Inflammatory markers available at the start of the therapy

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): NCT02294695


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

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Responsible Party: Domonkos Trásy, Ph.D. student; Department of Anaesthesiology and Intensive Therapy, Szeged University
ClinicalTrials.gov Identifier: NCT02294695     History of Changes
Other Study ID Numbers: EProK study
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: November 2014
Keywords provided by Domonkos Trásy, Szeged University:
Empiric antibiotic therapy
Additional relevant MeSH terms:
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Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents