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. 2012 Sep 12;2012(9):CD007498. doi: 10.1002/14651858.CD007498.pub2

Schroeder 2009

Methods Randomised clinical trial, single‐centre, surgical ICU in Germany
Participants Inclusion criteria: patients after abdominal surgery with antibiotic treatment because of severe sepsis in the surgical ICU
Exclusion criteria: patients were excluded if they did not meet the respective inclusion criteria, refused informed consent or already had received antibiotic treatment prior to admission to the ICU
Included in this analysis: 8 out of 27 randomised patients: 19 not considered for this analysis due to diagnosis other than RTI
Interventions Guiding antibiotic decisions in postoperative patients in a surgical ICU
Algorithm used in this study: in the procalcitonin‐guided group, antibiotic therapy was discontinued if clinical signs and symptoms of sepsis improved and procalcitonin values either had decreased to 1 µg/L or less or had dropped to 25% to 35% of the initial procalcitonin concentration over 3 consecutive days
Outcomes
  • Antibiotic use

  • Mortality (ICU‐free days alive)

Notes Funding: NA
Follow‐up: until hospital discharge
Registration: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unconcealed drawing of lots
Allocation concealment (selection bias) High risk Unconcealed drawing of lots
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Open‐label trial where physicians knew in which group patients were and where procalcitonin levels were only communicated in the intervention arm
Blinding of outcome assessment (detection bias) All outcomes High risk Non‐blinded study members
Incomplete outcome data (attrition bias) All outcomes Low risk Follow‐up for mortality: 8/8 (100% until discharge)
Selective reporting (reporting bias) Low risk No selective reporting (oral verification with first author)
Other bias Unclear risk Adherence to procalcitonin protocol not reported/assessed