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

Bacterial Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02311816
• Other study ID #: PCT-infection
• Status: Completed
• Phase: N/A
• First received: December 4, 2014
• Last updated: December 4, 2014
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Clinical Research Coordination Center Institutional Ethics Review Board for Human Research, University of Szeged: Hungary
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections

Locations

Country	Name	City	State
Hungary	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (1)

Lead Sponsor	Collaborator
Domonkos Trásy

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procalcitonin kinetic	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.	24 hours before starting empiric antibiotic treatment	No
Secondary	C-reactive protein kinetic	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.	24 hours before starting empiric antibiotic treatment	No
Secondary	Body temperature kinetic	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.	24 hours before starting empiric antibiotic treatment	No
Secondary	White blood cell count kinetic	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.	24 hours before starting empiric antibiotic treatment	No