Randomized placebo controlled trial of furosemide on subjective perception of dyspnoea in patients with pulmonary oedema because of hypertensive crisis

Eur J Clin Invest 2011; 41 (6): 627–634 Background To compare the administration of furosemide with placebo on the subjective perception of dyspnoea in patients with acute pulmonary oedema because of hypertensive crisis. Design Randomized, controlled and double‐blinded clinical trial. Setting: Municipal emergency medical service system and university‐based emergency department. Participants: Fifty‐nine patients with pulmonary oedema because of hypertensive crisis. Interventions: Additional to administration of oxygen, morphine‐hydrochloride and urapidil until the systolic blood pressure was below 160 mmHg, the patients were randomized to receive furosemide 80 mg IV bolus (furosemide group) or saline placebo (placebo group). Main outcome measures: The primary outcome was the subjective perception of dyspnoea as measured with a modified BORG scale at one hour after randomization. Secondary outcome parameters were the subjective perception of dyspnoea of patients as measured with a modified BORG scale and a visual analogue scale at 2, 3 and 6 h after randomization of the patient; course of the systolic arterial pressure and peripheral oxygen saturation and lactate at admission and at 6 h after admission. Results In 25 patients in the furosemide group and in 28 patients in the placebo group, a BORG score could be obtained. There was no statistically significant difference in the severity of dyspnoea at one hour after randomization (P = 0·40). The median BORG score at 1 h after randomization in the furosemide group was 3 (IQR 2 to 4) compared to 3 (IQR 2 to 7) in the placebo group (P = 0·40). Those patients who were randomized to the placebo group needed higher doses of urapidil at 20 min after randomization. There were no significant differences in the rate of adverse events, nonfatal cardiac arrests or death between the two groups. Conclusions The subjective perception of dyspnoea in patients with hypertensive pulmonary oedema was not influenced by the application of a loop‐diuretic. Therefore, additional furosemide therapy needs to be scrutinized in the therapy of these patients.