Septic ShockNCT07657754
Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock
A study testing Esmolol intravenous infusion in people with Septic Shock and Sepsis, run by First Affiliated Hospital of Wannan Medical College at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Septic Shock, Sepsis, Critical Illness Sepsis, Severe
- What is being tested?
- Esmolol intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhu, 233000
Cheng Liu, +86-18109657129, 3117999213@qq.com
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241000
qiancheng Xu, +86-18297529106, qianchengxu@wnmc.edu.cn
About this study
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
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.
Read the detailed description
Septic shock is characterized by profound circulatory dysfunction involving both systemic hemodynamics and the microcirculation. Persistent tachycardia is common in septic shock and may reflect sympathetic overactivation, high catecholamine exposure, fever, pain, hypovolemia, or ongoing circulatory stress. After adequate fluid resuscitation, vasopressor support, analgesia and sedation, and correction of reversible causes, persistent tachycardia may contribute to increased myocardial oxygen consumption, impaired diastolic filling, reduced ventriculo-arterial coupling, and altered tissue perfusion.
Esmolol is an ultra-short-acting β1-selective adrenergic blocker that can be titrated rapidly and discontinued promptly if adverse hemodynamic effects occur. Previous studies suggest that heart rate control with esmolol in selected patients with septic shock may reduce catecholamine requirements and improve cardiovascular efficiency. However, its immediate effects on sublingual microcirculation and vascular-waterfall physiology remain insufficiently characterized.
The vascular-waterfall phenomenon refers to the concept that tissue perfusion may depend not only on arterial and venous pressures but also on the relationship between upstream pressure, critical closing pressure, and mean systemic filling pressure. In septic shock, changes in vascular tone, vasopressor exposure, and microvascular regulation may alter critical closing pressure and the effective pressure gradient for tissue perfusion. Evaluating these parameters together with direct sublingual microcirculatory imaging may provide mechanistic insight into the physiological effects of esmolol beyond conventional macrocirculatory variables.
This is a prospective, multicenter, single-arm interventional pilot study conducted in adult intensive care unit patients with septic shock. Patients will be screened after initial hemodynamic optimization. Eligible patients must have septic shock according to Sepsis-3 criteria, persistent tachycardia, ongoing norepinephrine support, adequate volume status or no significant fluid responsiveness, and preserved or hyperdynamic cardiac function before esmolol initiation. Patients with shock predominantly due to non-septic causes, severe cardiac dysfunction, contraindications to β-blockade, or inability to obtain acceptable sublingual microcirculatory images will be excluded.
After informed consent is obtained, baseline measurements will be performed immediately before esmolol initiation. Participants will then receive continuous intravenous esmolol infusion. The infusion may be started at a low dose and titrated according to heart rate, mean arterial pressure, cardiac output or cardiac index, vasopressor requirement, and clinical safety criteria. Temporary dose reduction, interruption, or discontinuation of esmolol will be permitted for safety reasons, including clinically significant hypotension, bradycardia, reduced cardiac output, worsening shock, new or worsening arrhythmia, or other adverse events judged by the treating physician or investigator.
Study assessments will be performed at baseline and at 3, and 6 hours after initiation of esmolol. Sublingual microcirculatory imaging will be used to assess microvascular flow index, perfused vessel density, proportion of perfused vessels, and microcirculatory heterogeneity index. Vascular-waterfall related variables will include estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient. Systemic hemodynamic and perfusion variables, including heart rate, mean arterial pressure, cardiac index, norepinephrine dose, arterial lactate, urine output, and predefined adverse events, will also be recorded.
Approximately 20 patients will be enrolled to assess feasibility and generate preliminary estimates of physiological changes after esmolol administration. The main analyses will describe changes from baseline in sublingual microcirculatory and vascular-waterfall parameters over the 6-hour observation period. Safety events and exploratory clinical outcomes may be summarized descriptively to inform the design of subsequent controlled trials.
- Conditions
- Septic Shock, Sepsis, Critical Illness Sepsis, Severe
- Being tested
- Esmolol intravenous infusion
- Keywords
- esmolol, sublingual microcirculation, microvascular flow index, critical closing pressure, mean systemic filling pressure, vascular waterfall, Septic Shock
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmolol intravenous infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Esmolol arm | Experimental | Adult patients with septic shock and persistent tachycardia after initial hemodynamic optimization will receive continuous intravenous esmolol infusion. Sublingual microcirculatory, vascular-waterfall, macrocirculatory, perfusion, and safety variables will be assessed at baseline and at 3, and 6 hours after esmolol initiation. Receives: Drug: Esmolol intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
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.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
Secondary outcomes (14)
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.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
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.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
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.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
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.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Estimated Mean Systemic Filling Pressure
Estimated mean systemic filling pressure will be calculated using predefined hemodynamic methods. The outcome is the change in Pmsf from baseline to each post-esmolol time point.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Heart Rate
Heart rate will be recorded at each study time point. The outcome is the change in heart rate from baseline to each post-esmolol time point.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Mean Arterial Pressure
Mean arterial pressure will be recorded from invasive arterial monitoring at each study time point. The outcome is the change in MAP from baseline to each post-esmolol time point.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Cardiac Index
Cardiac index will be measured using echocardiography, pulse contour analysis, transpulmonary thermodilution, or other clinically available hemodynamic monitoring methods. The outcome is the change in cardiac index from baseline to each post-esmolol time point.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Norepinephrine Dose
Norepinephrine dose will be recorded in μg/kg/min at each study time point. The outcome is the change in norepinephrine dose from baseline to each post-esmolol time point.
Measured: Baseline, 3 hours, and 6 hours after initiation of esmolol.
Change From Baseline in Arterial Lactate
Arterial lactate concentration will be measured according to routine clinical practice. The outcome is the change in lactate from baseline to 6 hours after initiation of esmolol.
Measured: Baseline and 6 hours after initiation of esmolol.
ICU Length of Stay
Number of days from ICU admission to ICU discharge.
Measured: From ICU admission to ICU discharge, assessed up to 28 days after enrollment
Ventilator-Free Days at Day 28
Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment.
Measured: 28 days after enrollment.
28-Day Mortality
All-cause mortality within 28 days after enrollment.
Measured: 28 days after enrollment.
Incidence of Prespecified Adverse Events
Prespecified adverse events include clinically significant hypotension, bradycardia, new-onset or worsening arrhythmia, reduction in cardiac index requiring treatment modification, escalation of vasopressor or inotropic support, interruption or discontinuation of esmolol for safety reasons, cardiac arrest, or other clinically significant events during the observation period.
Measured: From initiation of esmolol to 6 hours after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive esmolol infusion and undergo repeated physiological assessments before and after treatment.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657754
- Sponsor's protocol ID
- 2026-ICU05
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07657754
- Acronym / sponsor ID
- 2026-ICU05
- Conditions
- Septic Shock, Sepsis, Critical Illness Sepsis, Severe
- Keywords
- esmolol, sublingual microcirculation, microvascular flow index, critical closing pressure, mean systemic filling pressure, vascular waterfall, Septic Shock
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Septic shock is characterized by profound circulatory dysfunction involving both systemic hemodynamics and the microcirculation. Persistent tachycardia is common in septic shock and may reflect sympathetic overactivation, high catecholamine exposure, fever, pain, hypovolemia, or ongoing circulatory stress. After adequate fluid resuscitation, vasopressor support, analgesia and sedation, and correction of reversible causes, persistent tachycardia may contribute to increased myocardial oxygen consumption, impaired diastolic filling, reduced ventriculo-arterial coupling, and altered tissue perfusion.
Esmolol is an ultra-short-acting β1-selective adrenergic blocker that can be titrated rapidly and discontinued promptly if adverse hemodynamic effects occur. Previous studies suggest that heart rate control with esmolol in selected patients with septic shock may reduce catecholamine requirements and improve cardiovascular efficiency. However, its immediate effects on sublingual microcirculation and vascular-waterfall physiology remain insufficiently characterized.
The vascular-waterfall phenomenon refers to the concept that tissue perfusion may depend not only on arterial and venous pressures but also on the relationship between upstream pressure, critical closing pressure, and mean systemic filling pressure. In septic shock, changes in vascular tone, vasopressor exposure, and microvascular regulation may alter critical closing pressure and the effective pressure gradient for tissue perfusion. Evaluating these parameters together with direct sublingual microcirculatory imaging may provide mechanistic insight into the physiological effects of esmolol beyond conventional macrocirculatory variables.
This is a prospective, multicenter, single-arm interventional pilot study conducted in adult intensive care unit patients with septic shock. Patients will be screened after initial hemodynamic optimization. Eligible patients must have septic shock according to Sepsis-3 criteria, persistent tachycardia, ongoing norepinephrine support, adequate volume status or no significant fluid responsiveness, and preserved or hyperdynamic cardiac function before esmolol initiation. Patients with shock predominantly due to non-septic causes, severe cardiac dysfunction, contraindications to β-blockade, or inability to obtain acceptable sublingual microcirculatory images will be excluded.
After informed consent is obtained, baseline measurements will be performed immediately before esmolol initiation. Participants will then receive continuous intravenous esmolol infusion. The infusion may be started at a low dose and titrated according to heart rate, mean arterial pressure, cardiac output or cardiac index, vasopressor requirement, and clinical safety criteria. Temporary dose reduction, interruption, or discontinuation of esmolol will be permitted for safety reasons, including clinically significant hypotension, bradycardia, reduced cardiac output, worsening shock, new or worsening arrhythmia, or other adverse events judged by the treating physician or investigator.
Study assessments will be performed at baseline and at 3, and 6 hours after initiation of esmolol. Sublingual microcirculatory imaging will be used to assess microvascular flow index, perfused vessel density, proportion of perfused vessels, and microcirculatory heterogeneity index. Vascular-waterfall related variables will include estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient. Systemic hemodynamic and perfusion variables, including heart rate, mean arterial pressure, cardiac index, norepinephrine dose, arterial lactate, urine output, and predefined adverse events, will also be recorded.
Approximately 20 patients will be enrolled to assess feasibility and generate preliminary estimates of physiological changes after esmolol administration. The main analyses will describe changes from baseline in sublingual microcirculatory and vascular-waterfall parameters over the 6-hour observation period. Safety events and exploratory clinical outcomes may be summarized descriptively to inform the design of subsequent controlled trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive esmolol infusion and undergo repeated physiological assessments before and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Esmolol arm | Experimental | Drug: Esmolol intravenous infusionAdult patients with septic shock and persistent tachycardia after initial hemodynamic optimization will receive continuous intravenous esmolol infusion. Sublingual microcirculatory, vascular-waterfall, macrocirculatory, perfusion, and safety variables will be assessed at baseline and at 3, and 6 hours after esmolol initiation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esmolol intravenous infusionEsmolol 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. | Drug | Esmolol arm |
Primary outcome
Change From Baseline in Sublingual Microvascular Flow Index
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
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
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
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.
14 secondary outcomes
Change From Baseline in Perfused Vessel Density
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Proportion of Perfused Vessels
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Microcirculatory Heterogeneity Index
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Estimated Critical Closing Pressure
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Estimated Mean Systemic Filling Pressure
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Heart Rate
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Mean Arterial Pressure
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Cardiac Index
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol
Change From Baseline in Norepinephrine Dose
Time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol.
Change From Baseline in Arterial Lactate
Time frame: Baseline and 6 hours after initiation of esmolol.
ICU Length of Stay
Time frame: From ICU admission to ICU discharge, assessed up to 28 days after enrollment
Ventilator-Free Days at Day 28
Time frame: 28 days after enrollment.
28-Day Mortality
Time frame: 28 days after enrollment.
Incidence of Prespecified Adverse Events
Time frame: From initiation of esmolol to 6 hours after initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esmolol intravenous infusion in people with Septic Shock and Sepsis, run by First Affiliated Hospital of Wannan Medical College at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qiancheng xu (+86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Sublingual Microvascular Flow Index (time frame: Baseline, 3 hours, and 6 hours after initiation of esmolol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.