Status:
COMPLETED
The Procalcitonin and Survival Study
Lead Sponsor:
Danish Procalcitonin Study Group
Collaborating Sponsors:
Copenhagen HIV Programme
Danish Research Agency
Conditions:
Localized Infection
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. In the ICU, the infectious sta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00271752
Start Date
January 1 2006
End Date
September 1 2009
Last Update
March 4 2010
Active Locations (9)
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1
Intensive Care Unit, Århus Sygehus, Nørrebrogade
Aarhus, Central Jutland, Denmark, DK-8000
2
Skejby Sygehus
Skejby, Århus, Central Jutland, Denmark, DK-8200
3
Intensive Care Unit, Bispebjerg Hospital
Copenhagen NV, Copenhagen, Denmark, DK-2400
4
Intensive Care Unit, KAS Gentofte
Gentofte Municipality, Copenhagen, Denmark, DK-2820