CompletedNot Applicable

The Procalcitonin and Survival Study

Denmark1,200 participantsStarted 2006-01

Plain-language summary

This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).

Who can participate

Age range18 Years

SexALL

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Inclusion 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

✕. 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

What they're measuring

mortality/survival

Timeframe: 28 day

Trial details

NCT IDNCT00271752

SponsorDanish Procalcitonin Study Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-09

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