Hoedemaekers 2005.
| Study characteristics | ||
| Methods | Randomised controlled trial Run‐in period: not specified Registration date: not available, published in 2005 Number of study centres and locations: unspecified, authors from University Hospital Nijmegen, the Netherlands |
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| Participants | Twenty participants were assessed in this study. Inclusion criteria: patients aged 18 years or older scheduled for elective CABG Exclusion criteria: history of diabetes, fasting blood glucose levels above 100 mg/dL on the day before surgery, MI within 4 weeks before surgery, cardiogenic shock or renal failure (serum Cr level above 1.7 mg/dL). Patients were also excluded if they had used any medication within 4 weeks before surgery known to modulate the inflammatory response (for example, nonsteroidal anti‐inflammatory drugs or steroids) or when there were clinical signs of infection or inflammatory disease. Patients undergoing off‐pump cardiac surgery were excluded. |
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| Interventions | Intervention: IT Control: standard glycaemic management |
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| Outcomes | Concentrations of the proinflammatory cytokines TNF‐α and IL‐ 6 and the anti‐inflammatory cytokine IL‐11 at 0 hours, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours after admission to the ICU | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details given around the randomisation method: "We performed a randomized, controlled study in 20 nondiabetic patients undergoing elective coronary bypass surgery" |
| Allocation concealment (selection bias) | Low risk | Sealed envelope: "Assignments to the treatment groups were made with the use of sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details given for blinding, unfeasible for study personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given, unlikely |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No trial group changes, no withdrawals, and no losses to follow‐up were reported, but no intention‐to‐treat analysis. Data from all the participants were included in the final analysis. |
| Selective reporting (reporting bias) | Unclear risk | Did not report graph for TNF‐α |
| Other bias | Low risk | The authors did not declare any financial support. "The authors declare that they have no competing interests." |