Evrard 2000.
Methods | RCT, parallel design | |
Participants |
Total number of randomized participants: 206 Inclusion criteria: undergone CABG without cardiac concomitant procedures Exclusion criteria: left ventricular ejection fraction < 35%, history of obstructive lung disease, known intolerance to beta‐blockers, history of recurrent or persistent SVT, ventricular tachycardia or fibrillation, postoperative aortic balloon pumping, renal failure, digoxin or other anti‐arrhythmic agents between surgery and randomization Type of surgery: elective CABG Baseline characteristics Intervention group (sotalol)
Control group (standard care)
Country: Belgium Setting: single centre; hospital |
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Interventions |
Intervention group (sotalol)
Control group (standard care)
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Outcomes |
Outcomes measured/reported by study authors: supraventricular and ventricular arrhythmias (to include 'runs of ventricular tachycardia'), length of hospital stay, mortality; MI; adverse events leading to discontinuation of treatment (to include asthma, mild heart failure, bradycardia, reduction in cardiac index, sinus tachycardia, moderate hypertension, ventricular extrasystoles) Outcomes relevant to the review: AF; length of hospital stay (see notes below), mortality; MI |
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Notes |
Funding/declarations of interest: not reported Study dates: not reported Note:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Blocked randomization in a prospective open manner" |
Allocation concealment (selection bias) | High risk | Blocked randomization in an unblinded trial |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial |
Blinding of outcome assessors (detection bias) All outcomes | High risk | Open‐label trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
Selective reporting (reporting bias) | Unclear risk | Study authors did not report prospective clinical trial registration or publication of a protocol. It was not feasible to effectively assess risk of reporting bias |
Other bias | High risk | Quote: "In patients with sustained SVT, trial medication was stopped and patients were treated according to the physician in charge by amiodarone or digitalization, or both, beta‐blockers, sotalol, or an increased dose of sotalol" Comment: in the control group, 15 participants were treated with beta‐blockers as rescue therapy for different reasons. This could influence outcome data |