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 hemod ynamic, respiratory and metabolic parameters in hypertensive patients with pulmonary edema, Design: Open, randomized and prospective clinica l study. Setting: Out-of-hospital setting and Emergency Department in a 2000-bed hospital, Patients: Hundred twelve patients with evidence o f hypertensive crises with pulmonary edema (systolic blood pressure (S BP) > 200 mm Hg and/or diastolic blood pressure (DBP) > 100 mm Hg and rales over both lungs) at the time when the emergency physician arrive d. Interventions: The out-of-hospital treatment consisted of oxygen vi a face mask, 80 mg furosemide i,v,, 10 mg morphium s. c., and either n itroglycerin sublingually (initial dose: 0.8 mg; repetitive administra tion of 0.8 mg every 10 min to a cumulative dose of 3.2 mg) or urapidi l (initial dose: 12.5 mg i.v,; repetitive administration every 15 min to a cumulative dose of 50 mg). If SEP was more than 180 mm Hg and/or DBP more than 90 mm Hg on admission, antihypertensive treatment was co ntinued with nitroglycerin (0.3-3 mg/h) or urapidil (5-50 mg/h). Measu rements and results: Blood pressure (BP) was measured every 5 min with the use of an automatic oscillometric device. Serum lactate, PO,, 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 mm Hg; 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 (PO,, 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 b etween the two groups were observed. Conclusion: The more pronounced B P reduction in the urapidil group was associated with an improved resp iratory and metabolic situation in hypertensive patients with pulmonar y edema. Therefore, urapidil is a valuable alternative to nitroglyceri n in patients with pulmonary edema and systemic hypertension.