The nitura study--effect of nitroglycerin or urapidil on hemodynamic, metabolic and respiratory parameters in hypertensive patients with pulmonary edema.

OBJECTIVE

To assess the effects of nitroglycerin or urapidil on hemodynamic, respiratory and metabolic parameters in hypertensive patients with pulmonary edema.

DESIGN

Open, randomized and prospective clinical study.

SETTING

Out-of-hospital setting and Emergency Department in a 2000-bed hospital.

PATIENTS

Hundred twelve patients with evidence of hypertensive crises with pulmonary edema (systolic blood pressure (SBP) > 200 mmHg and/or diastolic blood pressure (DBP) > 100 mm Hg and rales over both lungs) at the time when the emergency physician arrived.

INTERVENTIONS

The out-of-hospital treatment consisted of oxygen via face mask, 80 mg furosemide i.v., 10 mg morphium s.c., and either nitroglycerin sublingually (initial dose: 0.8 mg; repetitive administration of 0.8 mg every 10 min to a cumulative dose of 3.2 mg) or urapidil (initial dose: 12.5 mg i.v.; repetitive administration every 15 min to a cumulative dose of 50 mg). If SBP was more than 180 mm Hg and/or DBP more than 90 mm Hg on admission, antihypertensive treatment was continued with nitroglycerin (0.3-3 mg/h) or urapidil (5-50 mg/h).

MEASUREMENTS AND RESULTS

Blood pressure (BP) was measured every 5 min with the use of an automatic oscillometric device. Serum lactate, PO2, pH value, and base excess (BE) were evaluated on admission and 6 h later. Blood pressure, serum lactate and BE on admission were significantly lower (SBP: 155 +/- 30 vs 179 +/- 33 mm Hg; p = 0.0002; DBP: 82 +/- 17 vs 93 +/- 19 mmHg; p = 0.001; lactate: 2.2 +/- 1.6 vs 3.9 +/- 2.7; p = 0.0001; BE: -1.9 +/- 3.9 vs -4.4 +/- 1.7; p = 0.0005) and PO2 and pH values were significantly higher in the urapidil group compared to the nitroglycerin group (PO2: 75 +/- 25 vs 66 +/- 17; p = 0.036; pH: 7.33 +/- 0.08 vs 7.29 +/- 0.09; p = 0.042). After 6 h no differences between the two groups were observed.

CONCLUSION

The more pronounced BP reduction in the urapidil group was associated with an improved respiratory and metabolic situation in hypertensive patients with pulmonary edema. Therefore, urapidil is a valuable alternative to nitroglycerin in patients with pulmonary edema and systemic hypertension.