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 |
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| 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 |
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| 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. |
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| 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. |
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| 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 |