Zebis 2007.
Study characteristics | ||
Methods | Double‐blind, randomized, placebo‐controlled | |
Participants | On‐pump CABG only; Randomization stratified by age (65 yrs) and pre‐op use of Beta‐blockers | |
Interventions | Amiodarone vs. placebo | |
Outcomes | AF; Stroke; Mortality | |
Follow‐Up | 5 days | |
Concurrent Antiarrhythmic Medications | Beta‐blockers | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computerized prospective randomization schedule" |
Allocation concealment (selection bias) | Low risk | "Each patient received a randomization number, which was recorded and sent by fax to the pharmacy... The pharmacy decoded the randomization number, prepared the appropriate infusion and pills, and forwarded them, together with a sealed opaque envelope containing the randomization assignment..." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | High risk | Intention‐to‐treat analysis stated, but not reported |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |
Intention‐to‐treat analysis | High risk | No |
ACE: angiotensin‐converting enzyme AF: atrial fibrillation AVNRT: atrioventricular nodal reentry tachycardia AVR: aortic valve replacement bpm: beats per minute CABG: coronary artery bypass graft CCBs: calcium channel blockers CV: cardiovascular ICU: intensive care unit LOS: length of stay SVT: supraventricular tachycardia tid: three times per day