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 mmHg 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 mmHg and/or DBP more than 90 mmHg 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 mmHg; 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.