Elliott 1990.
Methods | Single‐site study (US). Open Label Method of randomization: not reported, Concealment of allocation: not reported Duration of treatment: 1 hour Follow‐up: 10 days. | |
Participants | 28 patients with high blood pressure and acute end organ damage * Inclusion criteria: All patients had supine diastolic blood pressure > 120 mm Hg in association with acute end organ damage. (decrease in creatinine, cardiomegaly, left ventricular hypertrophy on ECG, > grade II fundoscopy abnormality. * Exclusion criteria: congestive heart failure * Baseline characteristics for the two randomized groups: Nitroprusside (N): n= 15 Fenoldopam (F): n = 13 Unless otherwise indicated, values are expressed as mean ± SD age ( years) N:42 ± 8 F: 51 ± 5 Race: black N:14/15 F:12/13, BP: (mm Hg) N:222/137 F:214/136 Presence previous of accelerated/ malignant HTN N:11/15 F:11/13 |
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Interventions | Nitroprusside (N): n= 15
Fenoldopam (F): n = 13 Dose regimen: IV Fenoldopam (dopamine1 receptor agonist) * Initial dose 0.1 mcg/kg/min and then increments of 0.05 ‐0.1 mcg/kg/min every 20 minutes to DBP 100‐110 mm Hg and stable for 1 hour. Then an oral treatment ( atenolol 100 mg and Furosemide 20 mg) was added. The IV drug was then taper down until stopping it. IV Nitroprusside Initial dose 0.5 mcg/kg/min and then increments of 0.25 ‐0.5 mcg/kg/min every 20 minutes to DBP 100‐110 mm Hg and stable for 1 hour. Then an oral treatment ( atenolol 100 mg and Furosemide 20 mg) was added. The IV drug was then taper down until stopping it. |
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Outcomes | Obtained from this trial for the two randomized groups: Nitroprusside (N): n= 15 Fenoldopam (F): n = 13 Total SAE: NR Mortality: NR Total non‐fatal CVE: NR Any CVE: NR Withdrawals due to adverse events: NR Blood Pressure: obtained from text, p.972, during treatment. Calculated weighted mean BP change: Fenoldopam: SBP‐34±18, DBP ‐30 ± 14 Nitroprusside: SBP‐48±19,DBP ‐32±12 Standard deviation of change was not reported but imputed from end point Heart rate: obtained from text, p.972, during treatment. Calculated weighted mean HR change: Fenoldopam: 4 ± 19 Nitroprusside: 6±11 Standard deviation of change was not reported but imputed from end point | |
Notes | Funding: Not reported Although it said that creatinine would be monitored for 48‐72 hours and BP and clinical assessment would be done at day 7 to 10, no BP or clinical data was reported for 48‐72 hrs or day 7‐10 . |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |