Prostacyclin in trauma patients with hemorrhagic shock–A Randomized Clinical Trial

Abstract

ABSTRACT Background A main cause of trauma morbidity and mortality is multiple organ failure (MOF) and endotheliopathy has been implicated. Pilot studies indicate that low-dose prostacyclin improves endothelial functionality in critically ill patients suggesting this intervention may improve trauma patient outcome. Methods We conducted a multi-center, randomized, blinded, clinical investigator-initiated trial in 229 trauma patients with hemorrhagic shock who were randomized 1:1 to 72 hours infusion of the prostacyclin analogue iloprost (1 ng/kg/min) or placebo. The primary outcome was the number of intensive care unit (ICU)-free days alive within 28 days of admission. Secondary outcomes included 28 -day all-cause mortality and hospital length of stay. Results The mean number of ICU-free days alive within 28 days was 15.64 in the iloprost group vs. 13.99 days in the placebo group (adjusted mean difference: -1.63 [95% CI -4.64 to 1.38], P = 0.28). The 28-day mortality was 18.8% in the iloprost group vs. 19.6% in the placebo group (odds ratio: 1.01 [95% CI 0.51 to 2.0], P = 0.97). The mean hospital length of stay was 19.96 days in the iloprost group vs. 27.32 days in the placebo group (adjusted mean difference: 7.84 days [95% CI: 1.66 to 14.02], P = 0.01). Conclusions Iloprost did not result in a statistically significant increase in the number of ICU-free days alive within 28 days of admission, whereas it was safe and a statistically significant reduction in hospital length of stay was observed. Further research on prostacyclin in shocked trauma patients is warranted. Level of evidence Level 2