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Table 3 Efficacy and safety endpoints

From: Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial

Primary endpoint:  • HR response (i.e. HR = 80–94 bpm) and maintenance thereof and no increase in vasopressor requirements during the first 24 h after treatment start Secondary endpoints:  • Change in vasopressor requirements over the study period (dose and duration)  • HR response (i.e. HR = 80–94 bpm) during the first 24 h after treatment start  • 28-day mortality (all cause)  • ICU mortality (all cause)  • Duration of ICU stay (survivors/non-survivors)  • Duration of hospital stay (survivors/non-survivors)  • SOFA score (as long as the patient is treated with vasopressors) on days 1, 2, 3, 4, 7, 10, 13, 16, 19, 22, 25, and 28  • Daily inotropic requirements (as long as the patient is treated with vasopressors) Safety endpoints:  • Incidence rate of bradycardic episodes requiring intervention  • Incidence of adverse events (AE)  • Incidence of serious adverse events (SAE)