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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02294695

Enrollment

209

Registered

2014-11-19

Start date

2012-10-31

Completion date

2013-10-31

Last updated

2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Keywords

Empiric antibiotic therapy

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

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

Countries

Hungary

Outcome results