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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)