Infection, sepsis
Conditions
Interventions
Measuring Presepsin from collected serum and plasma during planned collection.
Sponsors
Roche Diagnostics GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Signed Informed ConsentAge > 18 yrs
Exclusion criteria
Exclusion criteria: Self-declared pregnancy or breast-feeding womenDependent of sponsor or investigatorknown/self-declared anemiaCongnitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The slope of the linear regression line of the presepsin concentrations measured after the two transport methods should be within a clinically reasonable range (slope 1.00 ± 0.15, and/or the correlation (Pearson’s r) > 0.900). After evaluating the results of the first 45 samples (equally distributed between the three concentration ranges), if the outcome is negatively conclusive, the study can stop, otherwise the collection of samples shall continue until up to 130 results approximately equally distributed between the given sample ranges are reached. Due to the desire for an even distribution, a maximum of 200 subjects are included. | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured concentrations of presepsin immediately after arrival are compared with the measured concentrations of presepsin at two time points the next day. This determines the stability at room temperature. Stability is determined by: Absolute deviation: recovery concentration Presepsin = 500 pg/mL: +/- 50 pg/mL Relative deviation: Presepsin > 500: +/- 10% | — |
Countries
Netherlands
Contacts
Public ContactN Geerts
Catharina Ziekenhuis
Outcome results
None listed