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. 2023 Oct 24;2023(10):CD013584. doi: 10.1002/14651858.CD013584.pub2

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:
  1. planned CABG with ≥ 4 or more grafts;

  2. planned valve surgery combined with CABG; or

  3. preoperative EF of < 40%.


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