This is a prospective, single arm, "roll-in" study of esmolol infusion for patients with septic shock with persistent tachycardia after adequate intravenous volume expansion. The study will evaluate the adequacy and efficiency of study protocols for the anticipated, main ECASSS study, which will have a separate entry in clinicaltrials.gov.
PRIMARY OBJECTIVE: To evaluate the adequacy and efficiency of study protocols for the anticipated, randomized, controlled ECASSS study. The primary clinical outcome is organ-failure free days at 28 days, with multiple secondary outcomes, including those relevant to function of and compliance with the study protocols.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Esmolol infusion
Intermountain Medical Center and Intermountain Clinics
Murray, Utah, United States
Organ-failure-free Days
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)
Time frame: Day 28
All-cause Mortality
Time frame: 90 days
Peak Serum High-sensitivity Troponin
Measured after enrollment.
Time frame: Troponin is measured on day 0 and day 1 (first day of esmolol infusion is day 0)
Left Ventricular Global Longitudinal Strain at 24 Hours
Time frame: Day 1
Development of Heart Block
Time frame: for duration of esmolol infusion, an expected average of 2 days
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