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

Completed

• Conditions: Bacterial Infection

• Registration Number: NCT02311816
• Lead Sponsor: Domonkos Trásy

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.

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-12
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-04
• Last Update Submitted: 2014-12-04
• Study First Posted: 2014-12-08
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procalcitonin kinetic	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

Name	Time	Method
White blood cell count kinetic	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.
Body temperature kinetic	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.
C-reactive protein kinetic	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.

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Szeged, Csongrád, Hungary