Data analysis plans for clinical studies of the Scandinavian INFECT cohort

 

1) Study of necrotizing soft tissue infections in patients with diabetes mellitus

  • Plan as of June 9, 2017

 

  • Primary outcome:

    • Mortality (90 Days)
  • Secondary outcomes:

    • ICU stay (days)
    • Hospital stay (days)
    • Amputation frequency
    • Infectious etiology
    • Locus of infection
    • Proportion of patients recieving CRRT
    • Number of days recieving CRRT
    • Proportion of patients with worsening of KDIGO/RIFLE-scores
     

 

  • Comparison within diabetic group:

    • Observed mortality rate vs estimated mortality rate according to SAPS