Kilger 2003.
| Study characteristics | ||
| Methods | Randomised controlled trial Run‐in period: Number of centres and location: not specified. Authors from Grosshadern University Hospital, LM‐University, Munich, Germany |
|
| Participants | A total of 91 participants were assessed in this study. Inclusion criteria:
Exclusion criteria: EF < 35% was an exclusion criterion in this study. Participants were also excluded if pregnancy, IL‐6 concentrations > 10 pg/mL preoperatively, hepatic insufficiency (bilirubin > 3 mg/dL), renal insufficiency (Cr > 2 mg/dL), a positive serologic test for HIV, manifest insulin‐dependent diabetes mellitus, adipositas permagna (BMI > 30), use of steroidal or nonsteroidal antiphlogistics during the last 7 days (except 100 mg of acetylsalicylic acid per day), an extracardial septic focus, or chronic or acute inflammatory diseases. |
|
| Interventions | Intervention: hydrocortisone. Loading dose (100 mg intravenously for 10 minutes) before induction of anaesthesia, followed by a continuous infusion of 10 mg/h for 24 hours (POD 1), which was reduced to 5 mg/h on POD 2, then tapered to 3 × 20 mg on POD 3 and 3 × 10 mg on POD 4 Control: placebo (0.9% sodium chloride) |
|
| Outcomes | IL‐6 before induction of anaesthesia and 6 hrs after termination of CPB (pg/mL), maximum dose of norepinephrine and epinephrine (g/kg) during the first 24 h duration of vasopressor or inotropic support, PaO2/FIO2 ratio after admission at the ICU, duration of mechanical ventilation, need for transfusion, lowest serum concentration of ATIII during the first 24 h, postoperative fluid requirement, postoperative blood loss, peak serum concentration of lactic acid during the first 24 h lowest pH value in the blood during the first 24 h, Simplified Acute Physiology Score II during the first 24 h in the ICU, Therapeutic Intervention Scoring System (TISS) daily during the stay in the ICU, length of stay (LOS) in the ICU and in hospital, mortality rate until discharge from the hospital | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details given |
| Allocation concealment (selection bias) | Unclear risk | No details given |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not in a double‐blind manner |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details given |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data included in analysis |
| Selective reporting (reporting bias) | Low risk | No reporting bias apparent |
| Other bias | Unclear risk | No details given |