Heart drug may unlock secrets of blood flow in sepsis
NCT ID NCT07657754
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how esmolol, a drug that slows the heart rate, affects the smallest blood vessels in people with septic shock—a severe infection that can lead to organ failure. Researchers will measure changes in blood flow under the tongue and other key pressures in the circulatory system. The goal is to understand these effects better, not to prove a treatment works. About 20 adults with septic shock and a fast heart rate will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- esmolol
- What this could lead to
- If successful, this could guide future treatments to improve blood flow in septic shock patients.
- What could go wrong
- This is a very small pilot study with only 20 patients, so results may not apply broadly. Esmolol can cause low blood pressure or slow heart rate.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhu, 233000, China
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The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can warming the body help sepsis patients who cannot make a fever?
- Can a simple ultrasound measurement reveal heart strain in sepsis?
- Chilling fever: can cooling septic shock patients save lives?
- Clotting clues: simple blood test eyed to catch sepsis before it turns deadly
- Bedside eye scans may reveal hidden blood flow problems in septic shock
- Can two blood markers catch sepsis before it turns deadly?