Effect of iloprost inhalation on postoperative outcome in high-risk cardiac surgical patients: a prospective randomized-controlled multicentre trial (ILOCARD)

Winterhalter, Michael; Rex, Steffen; Stoppe, Christian; Kienbaum, Peter; Müller, Hans-Helge; Kaufmann, Ines; Kuppe, Hermann; Dongas, Aristidis und Zwissler, Bernhard (2019): Effect of iloprost inhalation on postoperative outcome in high-risk cardiac surgical patients: a prospective randomized-controlled multicentre trial (ILOCARD). In: Canadian Journal of Anesthesia-Journal Canadien D Anesthesie, Bd. 66, Nr. 8: S. 907-920

Abstract

PurposePerioperative right ventricular (RV) failure due to pressure overload from pulmonary hypertension (PH) worsens postoperative outcomes after cardiac surgery. Inhaled iloprost is a potent pulmonary vasodilator improving RV performance, ameliorating myocardial and pulmonary ischemia-reperfusion injury and attenuating inflammation. We hypothesized that the prophylactic inhalation of iloprost would reduce postoperative ventilation times after cardiac surgery.MethodsIn this phase III, multicentre, randomized, double-blind, placebo-controlled trial, we randomly assigned 253 cardiac surgical patients at high risk of perioperative RV failure to the prophylactic inhalation of 20 mu g iloprost or placebo before and during weaning from extracorporeal circulation. The primary endpoint was the duration of postoperative ventilation. Secondary endpoints included perioperative hemodynamics, intensive care unit and hospital length of stay, and 90-day mortality. Safety was assessed by the incidence of adverse events.ResultsIloprost had no significant effect on the median [interquartile range] duration of postoperative ventilation compared with placebo (720 [470-1170] min vs 778 [541-1219] min, respectively;median decrease, 65 min;95% confidence interval [CI], -77 to 210;P = 0.37). While the nebulization of iloprost decreased RV afterload and improved cardiac index, major secondary endpoints were not significantly affected. Ninety-day mortality occurred in 14% of the iloprost patients compared with 14% of the placebo patients (hazard ratio, 0.97;95% CI, 0.50 to 1.89;P = 0.93). The incidence of adverse events was comparable in both groups.ConclusionsThe prophylactic inhalation of iloprost did not meaningfully improve the outcome in high-risk cardiac surgical patients.Trial registrationwww.clinicaltrials.gov (NCT00927654);registered 25 June, 2009.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0832-610X
• Sprache: Englisch