Yang 2004.
Methods | Single‐site study (Korea) Open label Method of randomization: NR Concealment of allocation : NR Duration of treatment: 1 hour Follow‐up: 1 hour | |
Participants | 40 patients with acute pulmonary edema and high blood pressure (SBP >160) Inclusion Criteria: Systolic pressure > 160 and a diastolic pressure > 100 mmHg accompanied by cardiovascular abnormalities and acute pulmonary edema Exclusion Criteria: Not stated * Baseline characteristics for the two randomized groups: Nitroprusside:(NTP) n = 20 Nicardipine (NIC) n= 20 Age (years) ± sd NTP:60 ± 14 NIC: 59±12 BP: (mm Hg) NTP:195/115; ± 27/20 NIC:196/114 ± 14/13 |
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Interventions | Nitroprusside infusion at a starting dose of 1 mcg /kg x min., for 1 hour
Nicardipine infusion at a starting dose of 3 mcg /kg per min for 1 hour
The dose regimen was titrated to maintain the BP at 80% of the initial mean arterial pressure. ‐mean dose given of NTP was 1.5‐mean dose given was 1.5±0.4 mcg/kg x min ‐mean dose given of NIC was 3.5±0.5mcg/kg per min Co‐interventions: NR |
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Outcomes | Outcomes obtained from this trial:
Total SAE: Not reported (NR)
Mortality: NR
Total Non‐fatal cardiovascular events: NR
Individual cardiovascular events: NR
Withdrawals due to adverse events: NR
Despite the author's statement that patients were to be remove from the study if they experience an excessive drop in BP , developed arrhythmia or respiratory difficulty , or became unresponsive or lost of consciousness, there is no report of these withdrawals. Blood pressure: Data was obtained from table 2 page 121. The calculated weighted mean BP change was: Nitroprusside: SBP‐41.25± 24; : DBP‐26.5±12 Nicardipine: SBP‐49± 23; : DBP‐30±12 Standard deviation of the change was not reported but imputed from end point Heart rate: Data was obtained from table 2 page 121. The calculated weighted mean HR change was: Nitroprusside: 2±16 Nicardipine: ‐1.5±20 Standard deviation of the change was not reported but imputed from end point |
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Notes | Funding: NR | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |
Glossary: AEOD=acute end organ damage NTP=sodium Nitroprusside NR=Not reported LVEF=left ventricular ejection fraction SBP =systolic blood pressure MAP=mean arterial pressure DBP=diastolic blood pressure HR=heart rate CO=cardiac output