Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

Completed

• Conditions: Bacterial Infections

• Registration Number: NCT02294695
• Lead Sponsor: Domonkos Trásy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-11
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procalcitonin kinetic	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

Name	Time	Method
Sequential Organ Failure Assessment score	The first six days after starting empiric antibiotic treatment	SOFA score is measured every day after starting empiric antibiotic treatment.

Trial Locations

Locations (1)

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