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NCT07657754

Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock

Sponsor: First Affiliated Hospital of Wannan Medical College

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2027-12-30

Last Updated

2026-06-18

Healthy Volunteers

Conditions

Septic Shock Sepsis Critical Illness Sepsis, Severe

Interventions

DRUG

Esmolol intravenous infusion

Esmolol 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.

Inclusion Criteria: Age 18-85 years. Diagnosis of septic shock according to Sepsis-3 criteria, requiring norepinephrine to maintain MAP ≥65 mmHg after adequate fluid resuscitation. Persistent tachycardia after initial hemodynamic optimization, adequate analgesia/sedation, and correction of reversible causes, defined as heart rate ≥95 beats/min. Continuous norepinephrine infusion for ≥6 hours, with norepinephrine dose ≥0.10 μg/kg/min at enrollment. Adequate volume status or absence of fluid responsiveness assessed by dynamic indices, echocardiography, or advanced hemodynamic monitoring; if PiCCO is used, GEDVI \>700 mL/m² and/or ITBVI \>850 mL/m² may be used as supportive criteria. Preserved or hyperdynamic cardiac function before esmolol initiation, defined as cardiac index \>3.0 L/min/m² or absence of severe septic cardiomyopathy. Ability to obtain sublingual microcirculatory images of acceptable quality at baseline. Written informed consent obtained from the patient or legally authorized representative. Exclusion Criteria: Shock mainly caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock. Severe cardiac dysfunction or severe septic cardiomyopathy, including cardiac index \<2.2 L/min/m² despite adequate preload, severe ventricular dysfunction, or need for inotropic agents at enrollment. Use of β-blockers before ICU admission or within 24 hours before enrollment. Contraindications to esmolol or β-blockade, including high-grade atrioventricular block without pacing, severe bradycardia, sick sinus syndrome, severe bronchospasm/asthma, or known allergy to esmolol. Severe structural heart disease or major pulmonary conditions affecting hemodynamics or safety, including severe valvular disease, significant congenital heart disease, cardiomyopathy, severe pulmonary bullae, or untreated pneumothorax. Acute coronary syndrome, life-threatening arrhythmia, or cardiac arrest before enrollment during the current ICU stay. Conditions interfering with sublingual microcirculatory assessment, including major oral/sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality. Pregnancy or lactation, expected death or withdrawal of life-sustaining treatment within 24 hours, expected ICU stay \<48 hours, or inability to obtain informed consent.

Locations (2)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, China

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhu, China