Sepsis
Conditions
Keywords
procalcitonin, duration of the antibiotic therapy, sepsis
Brief summary
Recently, biomarkers like procalcitonin have been studied in order to help physicians to decrease the duration of the antibiotic therapy. The investigators objective was to assess whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy in critically ill patients with a proven infection without risking a worse outcome.
Interventions
The patients assigned to the procalcitonin group had procalcitonin and C reactive protein levels measured at day 0 (bacteremia), 5 or 7 (if positive blood culture) and then every 48 hours until hosptital discharge, death or until the antibiotics were stopped. A predefined procalcitonin protocol was used together with the clinical outcome, to guide the physician´s decision to discontinue antibiotics. The procalcitonin protocol encouraged the physician to discontinue the antibiotics when: 1)procalcitonin dropped more than 90% from the baseline peak level or 2)an absolute value below 0,5ng/mL was reached. Cases in which the antibiotic treatment was continued against what the PCT values indicated were categorized as antibiotic discontinuation overruling
Sponsors
Hospital Israelita Albert Einstein
Study design
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all patients admitted in the intensive care unit with sepsis, severe sepsis and septic shock with a microbiologically confirmed infection (blood, urine, tracheal aspirate or bronchoalveolar fluid culture)
Exclusion criteria
* onset of the antibiotic therapy more than 48 hours before the date when the cultures were performed * patients less than 18 years old * known pregnancy * infections requiring prolonged antibotic therapy such as endocarditis, hepatic or brain abscess, deep abscess, mediastinitis and osteomyelitis * severe infection caused by virus, parasites, fungi or chronic prostatitis * negative cultures in patients with suspected sepsis, severe sepsis or septic shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reducing the duration of antibiotic therapy | 2 years | the primary objective was to assess if a procalcitonin measurement protocol can reduce the duration of antibiotic therapy in critically ill patients with sepsis, severe sepsis and septic shock with documented infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all cause mortality | 2 years | The secondary endpoints were in-hospital mortality, ICU mortality, ICU length of stay, recurrence of the initial infection, analyis of the C-reative protein levels along with the procalcitonin protocol and costs |
Countries
Brazil
Outcome results
None listed