The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitoninand pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients

Table 1 Data registration at time points in the patient course in the intensive care unit.

Evaluation	Day (screening & baseline)			Day (counting after admission to ICU) (follow-up)
	1	2 thru 28 or dis-charge	Day = Discharge/death	28	30	60	90	180
Informed Consent	X
Entry Criteria	X
Demography	X
APACHE II/SOFA	X	X	X
Infections during this hospital admission	X	X
Current medical conditions	X	X	X
State of daily function and health	X				X			X
Mortality		X	(X)	X		X	X	X
PCT	X	X	X
AUC_{procalcitonin}			X
Concurrent Medications^a	X	X	X		X	X	X	X
Haematology	X	X	X
Clinical chemistry	X	X	X
Adverse events	X^a		X
Serious Adverse Events	X^a	X	X		X	X	X	X

All data are registrered real-time in case report forms and according to the Good Clinical Practice legislation and guidelines. Clinical and laboratory Evaluations
a Adverse events and serious adverse events are registered daily
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ISSN: 1471-2334