Beltrame 1998.
| Methods | Single‐site study (Australia). Open‐label Method of randomization: NR Concealment of allocation : NR Follow‐up: until discharge from hospital Duration of treatment 24 hours | |
| Participants | 69 patients with elevated blood pressure and cardiogenic pulmonary edema (within 6 hours of onset) * Inclusion criteria: Acute onset of dyspnea within the preceding 6 hours, clinical findings consistent with pulmonary edema (increased respiratory work, gallop rhythm,widespread crepitations in the absence of chest infection or aspiration); radiological evidence of pulmonary edma * Exclusion criteria: Non cardiogenic pulmonary edema, cardiogenic shock ( SBP < 90). An overt AMI, valvular heart disease, obstructive airways disease, requiring immediate intubation, or cardioversion, or known in chronic renal failure * Baseline characteristics for the two randomized groups Furosemide/ morphine (F) (n=32) Nitroglycerin/ N‐acetylcysteine (N) (n=37) Note: Screened 87, (18 excluded‐ 10 ami, 3 chronic renal failure, 4 required immediate intubation, 1 unable to provide consent) Of 69 randomized, 4 were subsequently shown not to have acute pulmonary edema, all were included ITT analysis Unless otherwise indicated, values are expressed as mean ± SD age ( years) F:77± 6.6 N: 76± 9 Race: NR SBP: (mm Hg) F:164 ± 34 N:161 ± 32 HR (bpm) F:111± 21 N:115±21 Patients previously receiving antihypertensive F:nitrates 11(34%), diuretics 18(56%), CCB 9(28%),BB 4(13%),digoxin 10(31%), ACEi10(31%) N:nitrates 12(32%), diuretics 21(57%), CCB 8(22%),BB 3(8%),digoxin 3(8%*), ACEi11(30%) Past history F: ischaemic heart disease 11(34%), Chronic heart failure 17(53%),diabetes 12(38%) hypertension18(56%) N: ischaemic heart disease 15(41%), Chronic heart failure 20(54%),diabetes 14(38%) hypertension13(35%) |
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| Interventions | Furosemide/ morphine (F) (n=32) Nitroglycerin/ N‐acetylcysteine (N) (n=37) Dose regimen: F: iv furosemide bolus 40 mg, second dose at 60 min, 3 and 24 hours. Morphine 1‐2 mg/5 min) to a maximum dose of 10 mg. (median dose received 80mg of furosemide, and 3 mg of morphine) N: intravenous nigroglycerin 2.5 mcg/min,( to max 10 mcg/min) at the same time patients receive N‐acetylcysteine at 6.6 ?g/min over 24 hours (median dose received 2.5 mcg /min during first hour) Assessment were performed at 30, 60, 3 hours, and 24 hours. Cointerventions: On arrival, patients were given 50 % oxygen , | |
| Outcomes | Obtained from this trial for the two randomized groups: Furosemide/ morphine (F) (n=32) Nitroglycerin/ N‐acetylcysteine (N) (n=37) Total SAE: NR Mortality : 3 patients died, but they were not reported according to group of allocation. Neither are reported the causes of death Total Non‐fatal CVE: NR AMI: Furosemide=4 /32 Nitroglycerin=6/37 Witdrawals due to adverse events: NR Blood Pressure: obtained from a table, p275, over 24 hours Calculated weighted mean BP change Furosemide: SBP ‐21± 23; DBP ‐13.25±15 Nitroglycerin: SBP‐23.75±22; DBP ‐16.25 ±19 Standard Deviation of change was not reported but Imputed from end point Heart Rate: also obtained from table: Calculated weighted mean HR change Furosemide: ‐13.25± 15 Nitroglycerin ‐16.25±19 Standard Deviation of change was not reported but Imputed from end point | |
| Notes | Funding: National Health and Medical Research Council of Autralia | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | High risk | C ‐ Inadequate |