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PCT levels were measured after the completion of all study enrolments, using a Time Resolved Amplified Cryptate Emission technology assay (TRACE®, Kryptor compact, PCTsensitive; Brahms AG; Hennigsdorf, Germany).
The study plans to initially enrol 4800 patients; however, a sample size re-estimation will be performed approximately 1.5 years after study start using baseline assumptions from study enrolments to that point.
During the first two study enrolments, it was noted that a bright red nasal discharge was observed in some study participants, and interpreted by bedside nurses as bloody nasal discharge.
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Fig. 1 Study enrolment.
Study enrolment covered Q4‐2009 and follow‐up was until 12/31/10.
The mean age at the study enrolment was 48.0 ± 15.8 years (interval 20 83 years).
Time of inclusion (H0) and study enrolment were considered as the time of ICU admission.
The study approval was obtained from the University of Calgary Conjoint Health Research Ethics Board CHREBB) and all study participants provided signed informed consent for study enrolment according to the Declaration of Helsinki.
This was confirmed either by prospective treatment after study enrolment (run-in cohort), or retrospectively, with blood levels of lithium and valproate at screening (non-run-in cohort).
Patients with either a positive blood culture (p = 0.01) or a positive PCR/ESI-MS (p = 0.005) had higher SOFA scores on study enrolment.
As mentioned, the study approval was obtained from the University of Calgary Conjoint Health Research Ethics Board CHREBB) and all study participants provided signed informed consent for study enrolment according to the Declaration of Helsinki.
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