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Completed

NCT Number: NCT02311816

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

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

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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, H-6725, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Domonkos Trásy

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 8, 2014
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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