Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients W… (NCT07657754) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock
China20 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-block…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing esmolol, a heart rate-slowing drug, in people with septic shock — a life-threatening emergency condition — so how would my or my loved one's current stability affect whether joining this kind of study is even a realistic option?
2The trial is measuring something called the 'sublingual microcirculation' and a pressure gradient called Pcc-Pmsf — can you explain what those measures tell us about how blood is actually reaching the body's tissues during septic shock, and why that matters for treatment decisions?
3Since this trial hasn't started recruiting yet, what is the standard-of-care treatment for septic shock right now, and how does that compare to what would happen if we waited or participated in this study once it opens?
4Esmolol slows the heart rate, which could carry risks in someone who is already critically ill — what are the known safety concerns with using this drug in septic shock, and how would my doctor monitor for problems during the trial?
5Because this is listed as Phase NA — meaning it may be a small observational or early mechanistic study rather than a large treatment trial — does that mean the goal is primarily to understand what's happening in the body rather than to directly improve outcomes for participants?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Sublingual Microvascular Flow Index
Timeframe: Baseline, 3 hours, and 6 hours after initiation of esmolol
2
Change From Baseline in Pcc-Pmsf Gradient
Timeframe: Baseline, 3 hours, and 6 hours after initiation of esmolol
Trial details
NCT IDNCT07657754
SponsorFirst Affiliated Hospital of Wannan Medical College