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

Hirschl 1997.

Methods Single‐site study (Austria). 
 Method of randomization/ allocation: not reported 
 Duration of treatment : until response or maximum allowed dose 
 Follow‐up:4 hrs
Participants 81 patients with elevated blood pressure and evidence of acute end organ damage
* Inclusion criteria:
Patients with systolic blood pressure > 200 mmHg ,and diastolic blood pressure > 110 mm Hg in association with clinical evidence of acute end organ damage ( encephalopathy, stroke, acute heart failure, angina, aortic dissection)
* Exclusion Criteria: 
 > 80 years old 
 Acute or chronic renal failure 
 Pheochromocytoma 
 Organ transplant 
 Pregnancy, 
 Lactation
* Baseline characteristics for the two randomized groups: 
 Nitroprusside (N): n= 35 
 Urapidil (U): n= 46 
 Unless otherwise indicated, values are expressed as mean ± SD 
 Age ( years) 
 N:58 ±14.9 
 U: 62±12.9 
 Race: NR 
 BP: (mm Hg) 
 N:211/109 
 U:215/107 
 Type of acute end organ damage on admission 
 Angina N:15 U:11 
 Neurological emergencies N:15 U:11 
 Acute heart failure N:2 U:7 
 Aortic dissection N:3 U:6
Interventions Nitroprusside (N): n= 35 
 Urapidil (U): n= 46
Dose regimen: 
 IV Urapidil (peripheral alpha1 receptor blocker and central 5‐HT1A ‐receptor agonist). Initial dose 12.5 mg and then 12.5 mg every 15 minutes to a maximum of 75 mg or response. 
 IV nitroprussiate . Initial dose of 0.5 mcg /kg/ min and then 0.5 mcg /kg/ min every 15 minutes to a maximum of 3 mcg /kg/ min or response.
Outcomes Obtained from this trial 
 Total SAE: NR 
 Mortality: NR 
 Total non‐fatal CVE: NR 
 Individual CVE: NR 
 Withdrawals due to adverse events: not reported 
 Blood pressure: 
 Except for baseline values data was obtained from the graph in page 887 (fig.2). Weighted mean BP change was calculated as follow: 
 Nitroprusside: SBP ‐58.4 ± 17; DBP ‐28.4 ± 12 
 Urapidil: SBP ‐37.6 ± 17; DBP ‐17.6 ± 13 
 Standard deviation of the change was not reported but imputed from end point. 
 Heart rate: 
 Weighted mean HR change (at minute 90) was provided in the text (p.886) as follow: 
 Nitroprusside: ‐8.2 ± 14 
 Urapidil: ‐9.2 ± 21 
 Standard error of the change was provided. We converted it to SD.
Primary outcome stated by authors:
Percentage of responders within 90 min after start of therapy, the number of primary responders with a re‐elevation of BP and the percentage of major adverse events in each group (Hypotension greater than 50% and heart rate >120 bpm and aggravation of clinical symptoms requiring immediate intervention) and minor adverse events ( subjective symptoms).
Secondary outcome: 
 Extent of BP reduction, time to achieve BP control and the cumulative dose of each drug.
Notes Funding: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear