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. 2008 Jan 23;2008(1):CD003653. doi: 10.1002/14651858.CD003653.pub3

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
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.
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 .
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear