Nelson 1983.
Study characteristics | ||
Methods | Prospective, randomised, between‐group study | |
Participants | Men aged between 35 and 65 years who fulfilled the study criteria were evaluated in a coronary care unit between 5 and 14 hours of the onset of symptoms of myocardial infarction | |
Interventions | Group I: intravenous bolus of frusemide (1 mg/kg) Group II: isosorbide dinitrate by intravenous infusion, commencing at 50 μg/kg and doubled every 30 minutes to a maximum of 200 μg/kg/h or until the mean systemic arterial pressure has been reduced by approximately 10 mmHg; the infusion was then continued at this dose |
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Outcomes | Systemic arterial pressure, pulmonary artery occluded pressure, heart rate, cardiac output, stroke volume and systemic vascular resistance | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients in the two randomised groups were well matched for age, site of infarct, plasma level of cardiac enzymes, and radiological evidence of left ventricular failure." Comment: method of randomisation is not described |
Allocation concealment (selection bias) | Unclear risk | Quote: "Patients in the two randomised groups were well matched for age, site of infarct, plasma level of cardiac enzymes, and radiological evidence of left ventricular failure." Comment: baseline characteristics, including age, site of infarct, plasma level of cardiac enzymes are similar between both groups; however, there is no description of the randomisation process or concealment |
Blinding (performance bias and detection bias) | Low risk | Quote: "The study was designed as a single‐blind between‐group comparison." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "No untoward incident occurred in any patient." Comment: no missing data from any treatment groups |
Selective reporting (reporting bias) | Low risk | Comment: all of the study's pre‐specified outcomes that are of interest in the review have been reported in the pre‐specified way |
Other bias | Low risk | Comment: the study appears to be free of other sources of bias |