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Abstract
Introduction
Invasive candidiasis (IC) is associated with increasing morbidity and mortality in
critically ill patients. This, in conjunction with difficulties in diagnosis, underscores
the need for novel treatment strategies based on the identification of significant
risk factors for IC. The aim of the study was to evaluate the efficacy and safety
of a protocol for pre-emptive antimycotic treatment.
Methods
A randomized prospective controlled trial was carried out in a general ICU for 2 years.
After the implication of the inclusion and exclusion criteria, patients were submitted
to block randomization and stratified on the basis of their initial SAPS II expanded
score. We have developed a protocol for pre-emptive antimycotic treatment. Having
reviewed the current literature, we combined the most significant risk factors for
IC with tree major clinical criteria for persistent nonbacterial sepsis and assumed
this algorithm as an indication for starting pre-emptive therapy. According to the
protocol, antimycotic therapy was started on the day of inclusion in the treatment
group and only with proven IC in the control group. Initial data were gathered on
demographic characteristics of the patients, proven risk factors for IC-related mortality
(malnutrition, non-albicans colonization, creatinine clearance) and severity of inflammatory
response and organ dysfunction. Dynamics of SIRS and SOFA, subsequent Candida isolates,
ventilator-free days, length of ICU stay, outcome and eventual adverse reactions were
followed.
Results
A total of 110 patients (equal in both groups) were enrolled. No statistically significant
differences in the basal characteristics of the patients, length of ICU stay and the
number of ventilator-free days were found. The delta SOFA score was significantly
lower in the treatment group (P = 0.019). The in-hospital mortality was 38.2% in the
treatment group vs 61.8% in the control group (P = 0.013). The associated with pre-emptive
therapy relative risk was 0.62 (95% CI = 0.4 to 0.94). Significant differences between
the Kaplan-Meyer estimates of survival were found (log-rank test P = 0.007). A total
of 15 (13.6%) adverse reactions were observed among treated patients in both groups
which was not associated with higher mortality risk.
Conclusions
The implementation of the developed protocol reduced the degree of organ dysfunction
severity and was associated with significant survival benefit.