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 |