Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

NCT02294695 | Completed

• 1 other identifier: EProK study
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections

Keywords

Empiric antibiotic therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sequential Organ Failure Assessment score

  The first six days after starting empiric antibiotic treatment

Other Outcomes (4)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients younger than 18 years
• 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

Sponsors & Collaborators

• Domonkos Trásy: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, H-6725, Hungary

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. student; Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 19, 2014
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 17, 2016

Record last verified: 2014-11

Locations

HU (1)