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

Schurr 2001.

Study characteristics
Methods Single‐centre, prospective, randomised controlled trial
Run‐in period: August 1999 and November 2000
Registration date: study published in 2001
Number of study centres and locations: single centre, authors from University Hospital Zurich, Zurich, Switzerland
Participants A total of 50 adults undergoing primary isolated CABG
Mean age: 64 years
Sex (female/male ratio): 0.16
Low‐risk patients (elective CABG)
Inclusion criteria: elective CABG, both sexes
Exclusion criteria: participants with insulin‐dependent diabetes mellitus, peptic ulcer history, malignant tumours, immunologic deficiencies, renal or hepatic insufficiency, and COPD
Interventions Group A (n = 24): 10 mg/kg MPSS (Solu‐Medrol; Pharmacia & Upjohn AG, Duebendorf, Switzerland) intravenously 4 hours before the operation
Group B (n = 26) served as a control.
Outcomes Preoperative blood samples (10 mL) were taken before the administration of 10 mg/kg body weight MPSS, delivered 4 hours before induction of anaesthesia. Postoperatively, blood samples were collected after 24 hours, 48 hours, and on the sixth POD. The following measurements were taken: IL‐2R, IL‐6, IL‐8, TNF‐α, and the soluble adhesion molecules sE‐selectin and sICAM‐1.
Medical history, demographic data, and the clinical course were analysed for each participant. Postoperatively, fluid balance; haemodynamic measurements; time on respirator; blood loss; occurrence of AF; renal, hepatic, and coagulation disorders; and pulmonary infection requiring antibiotic treatment were registered, as well as the duration of ICU stay and hospitalisation.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors state that participants were randomised, but process was not described: "…Fifty patients undergoing elective coronary operations under normothermic CPB were randomized into two groups".
Allocation concealment (selection bias) Unclear risk No details given around concealment of allocation
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No blinding of participants and personnel described
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No clear details given
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) High risk Some prespecified outcomes are not reported, i.e. IL‐8, IL‐2, and sICAM‐1 authors state "…were also reduced, but again the difference did not reach statistical significance", but no values are reported.
Other bias Unclear risk No statement provided with regard to possible conflict of interest