Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

Early Procalcitonin Kinetics May Indicate Effectiveness of the Empirical Antibiotic Therapy in Sepsis Within Hours

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, H-6725
      • Department of Anaesthesiology and Intensive Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procalcitonin kinetic	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.	The first six days after starting empiric antibiotic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequential Organ Failure Assessment score	SOFA score is measured every day after starting empiric antibiotic treatment.	The first six days after starting empiric antibiotic treatment

Other Outcome Measures

Outcome Measure	Time Frame
Length of Intensive Care Unit stay	Maximum 90 days after enrollment
Intensive Care Unit mortality	Maximum 90 days after enrollment
Length of hospital stay	Maximum 90 days after enrollment
Hospital mortality	Maximum 90 days after enrollment

Collaborators and Investigators

• Sponsor: Domonkos Trásy

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Empiric antibiotic therapy
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: EProK study