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 |
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| 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 |
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| Outcomes |
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| Notes |
Funding: NA Follow‐up: until hospital discharge Registration: none |
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| 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 |