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

From: 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

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      
AUCprocalcitonin    X      
Concurrent Medicationsa X X X   X X X X
Haematology X X X      
Clinical chemistry X X X      
Adverse events Xa   X      
Serious Adverse Events Xa X X   X X X X
  1. All data are registrered real-time in case report forms and according to the Good Clinical Practice legislation and guidelines. Clinical and laboratory Evaluations
  2. a Adverse events and serious adverse events are registered daily
  3. THIS PROTOCOL IS A SHORT AND MODIFIED EDITION FOR PUBLICATION: THE FULL LENGTH PROTOCOL (41 pages) WITH ALL REFERENCES CAN BE REQUIRED UPON REQUEST FROM THE AUTHORS.