A placebo-controlled trial verifying the efficacy of milrinone in weaning high-risk patients from cardiopulmonary bypass

Objective: To establish the efficacy of the phosphodiesterase inhibitor milrinone in facilitating weaning from cardiopulmonary bypass of high-risk patients with left ventricular dysfunction and/or pulmonary hypertension. Design: A double-blinded, placebo-controlled longitudinal study. Setting: A university teaching hospital. Participants: Thirty-two patients with preoperative left ventricular ejection fraction less than or equal to 35% and/or mean pulmonary artery pressure greater than or equal to 20 mmHg were studied after their written informed consent. Intervention: Patients were randomized to commence either intravenous milrinone, 50 mu g/kg loading dose over 20 minutes followed by 0.5 mu g/kg/min infusion, or matching placebo 15 minutes before withdrawal of cardiopulmonary bypass. Measurements and Main Results: Two patients were withdrawn from the study and their results not analyzed: one because of early failure of hemodynamic monitoring and the other because of gross surgical bleeding. In the remaining 30 patients, who were well matched for clinical and baseline hemodynamic variables, bypass support was successfully withdrawn in all 15 patients randomized to receive milrinone but in only 5 of the 15 patients randomized to receive placebo. In the 10 patients who initially failed to wean from bypass while on placebo, bypass was reinstituted and open-label milrinone was administered in the dose outlined. After treatment with open-label milrinone, these patients could also be withdrawn from bypass support, During the period of hemodynamic monitoring, cardiac index increased in both milrinone- and placebo-treated patients, although this change was greater in those treated with milrinone. Perhaps related to routine clinical treatment, there were no significant differences between the two groups with mean pulmonary artery or pulmonary capillary wedge pressures, the other major hemodynamic endpoints. There were no significant adverse effects related to milrinone. Conclusions: This placebo-controlled, double-blind study has conclusively demonstrated the benefits of milrinone in facilitating weaning of high-risk patients from cardiopulmonary bypass. Copyright (C) 1997 by W.B. Saunders Company.