Trial Outcomes & Findings for Esmolol Infusion for Patients With Septic Shock and Persistent Tachycardia (NCT NCT02841241)

Esmolol Infusion for Patients With Septic Shock and Persistent Tachycardia

As of day 28, the number of calendar days on which the patient receives none of (a) vasopressor therapy, (b) mechanical ventilation, or (c) renal replacement therapy. If the patients dies on or before day 28, they have -1 organ-failure-free days. The resulting point-based score combines the probability of death and the number of days without organ failure. Score of -1 = Death before day 28 (Lowest Score). Score of 28 = Patient has been successful at going 28 without any vasopressor therapy/mechanical ventilation/renal replacement therapy (Highest Score)

Measured after enrollment.

For the esmolol titration protocol, each hour (the closest value of heart rate to the hour) during the esmolol infusion will be determined to be "in range" or "out of range," with 3bpm margin for compliance (i.e., heart rate 77 to 93bpm). The initiation and cessation of esmolol will also be included as a timepoint for evaluation of compliance. Protocol compliance is considered adequate where overall compliance on hourly checks is \>80%.

Patients who met a prespecified stop event for esmolol titration, suggesting intolerance to a given infusion rate. Per protocol, study drug titration: "The target heart rate is 85 bpm. Start study drug infusion at 20 mcg/kg/min, without bolus, if HR (heart rate) ≥ 100 bpm. If HR \>90 bpm and \<100 bpm, start study drug infusion at 10 mcg/kg/min, without bolus. Increase by 20 mcg/kg/min every 20 minutes as long as HR \> 90 bpm, to a maximum dose of 100 mcg/kg/min. If HR \< 80 bpm and \> 70 bpm, decrease infusion rate by 10 mcg/kg/min; if HR ≤ 70 bpm and \> 60 bpm, decrease infusion rate by 20 mcg/kg/min."