Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294695
• Other study ID #: EProK study
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: June 16, 2016
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: November 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• 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

• 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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
Other	Length of Intensive Care Unit stay		Maximum 90 days after enrollment	No
Other	Intensive Care Unit mortality		Maximum 90 days after enrollment	No
Other	Length of hospital stay		Maximum 90 days after enrollment	No
Other	Hospital mortality		Maximum 90 days after enrollment	No
Primary	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	No
Secondary	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	No