Hochreiter 2009
| Methods | Randomised clinical trial, single‐centre, intensive care unit in Germany | |
| Participants |
Inclusion criteria: patients in the surgical ICU with suspected bacterial infections and > 1 SIRS criteria Exclusion criteria: patients who refused study consent, whose antibiotic treatment had been initiated before intensive care admission, or who had therapy limitations Included in this analysis: 43 (110): 67 not considered for this analysis due to diagnosis other than ARI |
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| Interventions | Guiding antibiotic decisions in postoperative patients in a surgical ICU Algorithm used in this study: AB therapy in the procalcitonin‐guided group was discontinued if clinical signs and symptoms of infection improved and procalcitonin decreased to less than 1 µg/L, or if the procalcitonin value was more than 1 µg/L, but had dropped to 25 to 35% of the initial value over 3 days |
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| Outcomes |
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| Notes |
Funding: BRAHMS AG Follow‐up: until hospital discharge Registration: ISRCTN10288268 |
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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: 393/394 (100%) |
| 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 |