Maravić‐Stojković 2011.
Methods | Randomised, single‐centre, open‐label, controlled clinical trial at a 200‐bed academic tertiary care hospital in Belgrade, Serbia | |
Participants | Inclusion criteria: People scheduled to undergo open heart surgery on cardio‐pulmonal bypass. We assessed people who were selected for elective cardiac surgery at the 200‐bed academic tertiary care hospital. The criterion for inclusion in the study was the type of operation: coronary artery bypass grafting (CABG) surgery, valve reconstruction, combined CABG and valve procedures. Entry criteria included stable and unstable angina pectoris, valve insufficiency, left ventricle ejection fraction (LVEF) above 30%, and epidemiological status with saprophyte bacteria. Exclusion criteria: People selected for redo cardiac operations, thoracic aortic surgery, as well as people having active endocarditis and people with LVEF < 30%. People with preoperative signs of infection (leukocyte count > 12,000/L; body temperature > 38°C) were also excluded. Included in this study: 205/205 included participants finished for follow‐up (102 PCT group/103 standard group). | |
Interventions | Guiding antibiotic decisions in patients after cardiac surgery Algorithm used in this study: Antibiotic prophylaxis was performed in all participants. The participants were divided at the time of surgery into the standard group and the PCT group. In the standard group, the antibiotic use was applied according to the criteria based on the laboratory and clinical signs; no antibiotic therapy was administrated routinely in the absence of clinical signs of infection or a bacteriologic positive sample. In the PCT group, the use of antibiotics was encouraged or discouraged on the basis of serum PCT concentrations. A serum PCT concentration of 0.5 ng/mL or less indicated the absence of bacterial infection, at which point the use of antibiotics was discouraged. |
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Outcomes |
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Notes | Funding: No funding is mentioned in the main article. Follow‐up: 1 year Trial registration: No trial registration found. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation scheme |
Allocation concealment (selection bias) | Low risk | The participants were divided at the time of surgery into the standard group and the PCT group by centralised randomisation. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No blinding of physicians due to the study design |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment mentioned in the study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up for mortality: 205/205 (100%) |
Selective reporting (reporting bias) | Unclear risk | No trial registration found. |
Other bias | Unclear risk | No information about adherence |