Procalcitonin Monitoring May Decrease Antibiotic Use in the Intensive Care Unit

• Conditions: Sepsis
• Interventions: Other: Literature search

• Registration Number: NCT01085994
• Lead Sponsor: University of Athens

Brief Summary

Sepsis is common and is associated with significant mortality, morbidity and health-care costs. Unfortunately, its diagnosis is not straightforward because its signs and symptoms are neither specific nor sensitive; in addition, microbiological cultures lack specificity, sensitivity and are plagued by high turn-around times. Because the delay in the institution of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU-patients, even when they are not needed. Procalcitonin may not be the long sought for bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the administered antibiotic courses once they are started.

Detailed Description

Recently, a number of studies have shown the utility of procalcitonin (PCT) measurements in reducing the duration of antibiotic treatment in patients with respiratory tract infections presenting to the primary care setting or the emergency department. However, it remains unclear if a similar strategy can be effectively and safely implemented in the critical care setting. We attempt to address the controversy on this issue, by collecting, analyzing and interpreting the currently available relevant evidence. To this end, a systematic review and meta-analysis of the randomized controlled trials reporting on the outcomes of critically ill septic patients managed with or without a procalcitonin-based algorithm will be performed.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Last Update Submitted: 2010-10-06
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Randomized controlled trials (RCTs) that report on the outcomes of critically ill patients managed with a procalcitonin-guided algorithm versus routine practice.
• Participants of any age with proven or suspected sepsis will be considered. - As routine practice, the investigators will consider the institution and discontinuation of antibiotics by the attending physicians with the aid of clinical signs, symptoms, microbiological data, well established laboratory parameters (i.e., white blood cell count) and widely accepted guidelines but without the knowledge of PCT values. The investigators will set no limitations regarding the time, country or language of publications. The investigators will search for trials conducted in critically ill neonates and children.

Exclusion Criteria

• The investigators will exclude studies that are not RCTs and studies performed outside the ICU, namely in the primary care setting, the emergency department or the clinic.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Procalcitonin-guided group	Literature search	-
Routine practice group	Literature search	-

Primary Outcome Measures

Name	Time	Method
Duration of antibiotic treatment for the first episode of infection
Total duration of antibiotic therapy
Antibiotic-free days at 28 days after study enrollment

Secondary Outcome Measures

Name	Time	Method
28-day mortality
In-hospital mortality
Length of ICU stay
Length of hospital stay
Days free of mechanical ventilation at 28 days after study enrollment
Rates of relapsed/persistent infection
Rate of superinfection
Financial cost of implementing a procalcitonin-based algorithm: purchase of the laboratory equipment/reagents, cost of the administered antibiotics, charges for hospital stay etc

Trial Locations

Locations (1)

University of Athens - Medical School; 🇬🇷 Athens, Greece