The Procalcitonin and Survival Study (PASS)
Localized Infection, Sepsis, Multiple Organ Failure
About this trial
This is an interventional treatment trial for Localized Infection focused on measuring Procalcitonin, Sepsis, Intensive Care Unit, Sepsis and Complications, Organ Failure
Eligibility Criteria
Inclusion Criteria: Fulfilment of all of the following three criteria: Male or female, aged > 18 years of age. Admitted to the participating Intensive Care Units (ICUs) at the following hospitals: Hvidovre Hospital, Bispebjerg Hospital, Amager Hospital, Herlev Hospital, Glostrup Hospital, and Gentofte Hospital Ability to understand and provide written informed consent to participate in this trial; or ability to understand and provide oral informed consent in the presence of at least one impartial witness who should sign and personally date the consent form; or the subject's legally acceptable representative can understand and provide written informed consent if the subject is not capable of this because of the present mental or physical condition of the subject. Exclusion Criteria: A subject will NOT be eligible for inclusion in this trial if any of the following criteria apply: Subjects with known hyperbilirubinaemia (> 0.4 mg/ml) or hypertriglyceridaemia (> 10 g/l) since this can interfere with measurements. If subjects with unknown status on these points are included and have PCT measurements, the measuring equipment will detect these conditions. Subjects suffering from a blood disorder, where daily sampling of 7 ml of blood for a maximum of 28 days (210 ml distributed on 28 days) will be an inconvenience or a potential risk, which could compromise the safety of the subject. Subjects who are pregnant or breast feeding The a priori probability of surviving with the normal recommended diagnostics and treatment with the presently available means to detect infections and, on the other hand, the normal diagnostics and treatment together with daily procalcitonin measurements and prompt clinical reaction should be equal.
Sites / Locations
- Intensive Care Unit, Bispebjerg Hospital
- Intensive Care Unit, KAS Gentofte
- Intensive Care Unit, KAS Glostrup, Copenhagen University Hospital
- Intensive Care Unit, Herlev Hospital
- Intensive Care Unit 542, Hvidovre Hospital, Copenhagen University Hospital
- Intensive Care Unit, Hilleroed Sygehus
- Skejby Sygehus
- Intensive Care Unit, Århus Sygehus, Nørrebrogade
- Roskilde Sygehus
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
PCT guided
Control
Procalcitonin guided treatment of infections in the ICU. Intervention: Intensification of antibiotics, surgery, microbiologic testing and diagnostic imaging, when Procalcitonin levels are increasing
These patients receive "Standard of Care" which is the recommended treatment in the given ICU