This prospective, multicenter, single-arm interventional pilot study aims to evaluate the short-term physiological effects of intravenous esmolol on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock. Eligible patients will have septic shock according to Sepsis-3 criteria, persistent tachycardia after initial hemodynamic optimization, ongoing norepinephrine support, adequate volume status or absence of significant fluid responsiveness, and preserved or hyperdynamic cardiac function.
Approximately 20 patients will be enrolled from participating intensive care units. After baseline assessment, participants will receive continuous intravenous esmolol infusion according to the study protocol and clinical safety criteria. Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline and at 3, and 6 hours after esmolol initiation. Additional systemic hemodynamic, perfusion, vasopressor, and safety variables will also be collected.
The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after esmolol administration and to provide preliminary data for the design of future controlled studies.
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Single group
Esmolol intravenous infusion
DrugEsmolol will be administered as a continuous intravenous infusion after initial hemodynamic optimization. The suggested initial infusion rate is 25-50 μg/kg/min and may be titrated according to heart rate, blood pressure, cardiac output, and clinical judgment. The target heart rate is generally 80-94 beats/min, unless individualized by the treating physician. Dose adjustment, temporary interruption, or discontinuation is permitted for safety reasons, including hypotension, bradycardia, reduced cardiac output, or other clinically significant adverse events. The actual dose and reasons for dose changes will be recorded at each study time point.
Change From Baseline in Sublingual Microvascular Flow Index
Microvascular flow index will be assessed using sublingual microcirculatory imaging. Three to five sublingual video fields will be recorded at each time point, and MFI will be calculated according to standard microcirculatory scoring methods. The outcome is the change in MFI from baseline to each post-esmolol time point.
Change From Baseline in Pcc-Pmsf Gradient
The vascular-waterfall pressure gradient will be calculated as the difference between estimated critical closing pressure and estimated mean systemic filling pressure. The outcome is the change in Pcc-Pmsf from baseline to each post-esmolol time point.
Change From Baseline in Perfused Vessel Density
Perfused vessel density will be measured from sublingual microcirculatory images. The outcome is the change in PVD from baseline to each post-esmolol time point.
Change From Baseline in Proportion of Perfused Vessels
Proportion of perfused vessels will be measured from sublingual microcirculatory images. The outcome is the change in PPV from baseline to each post-esmolol time point.
Change From Baseline in Microcirculatory Heterogeneity Index
Microcirculatory heterogeneity index will be calculated from sublingual microcirculatory measurements. The outcome is the change in HI from baseline to each post-esmolol time point.
Change From Baseline in Estimated Critical Closing Pressure
Estimated critical closing pressure will be calculated using predefined hemodynamic methods. The outcome is the change in Pcc from baseline to each post-esmolol time point.
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First Affiliated Hospital of Wannan Medical College
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Collaborator
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