Septic ShockPhase 1/2Epic-BetaNCT07313605
POCUS-Guided Esmolol in Septic Shock: A Pilot RCT
A Phase 1/2 study testing Esmolol in people with Septic Shock, run by John Basmaji.
Trial summary
The goal of this pilot clinical trial is to determine if conducting a larger study using point-of-care ultrasound (POCUS) to guide beta-blocker therapy in patients with septic shock is feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 Apr 2028
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Within 24 hours of diagnosis of septic shock based on Sepsis-3 criteria (requirement for vasopressors to maintain organ perfusion, lactate greater than 2 mmol/L, suspected or confirmed infection)
- Within 72 hours of ICU admission
- Tachycardia with heart rate 100 beats per minute or greater, defined as either sinus tachycardia or atrial fibrillation/flutter
Who cannot join
- Known allergy to beta-blockers
- Second or third-degree heart block without a functioning pacemaker
- Acute bronchospasm or status asthmaticus
- Pregnancy
- Patient receiving extracorporeal membrane oxygenation
- Decision to limit life-sustaining therapies
Show all 10Show fewer
- Untreated pheochromocytoma
- Fluid-responsive patients as determined by POCUS assessment
- Moderate to severe right ventricular and/or systolic left ventricular dysfunction as determined by POCUS assessment
- Patient already receiving calcium channel blocker or beta-blocker therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Beta-Blocker Therapy Versus Standard Care in Patients With Septic Shock: A Pilot Randomized Controlled Trial Utilizing Predictive Enrichment With Point-of-Care Ultrasound
The goal of this pilot clinical trial is to determine if conducting a larger study using point-of-care ultrasound (POCUS) to guide beta-blocker therapy in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure, requiring medications to support the heart and circulation. In septic shock, the body's stress response causes the heart to beat too fast, which can worsen organ damage.
Beta-blockers are medications that slow the heart rate and may improve outcomes, but previous studies have shown mixed results. Some patients may be harmed by beta-blockers if they have not received enough fluids or if their heart is not functioning well. This study uses ultrasound to identify patients who are most likely to benefit and least likely to be harmed by beta-blocker therapy.
Read more
The main questions this study aims to answer are: Is it feasible to recruit patients, obtain consent, perform ultrasound screening, and follow the study protocol? Researchers will compare two groups: one receiving the beta-blocker esmolol versus another receiving standard care, to assess the feasibility of a larger trial.
Participants in the esmolol group will receive an intravenous infusion titrated to achieve a target heart rate of 75-95 beats per minute for up to 5 days or until shock resolves. All participants will be monitored for 90 days to track survival and organ function.
Read the detailed description
Septic shock remains a leading cause of intensive care unit admissions and mortality worldwide, with approximately 50% of affected patients dying. Excess beta-adrenergic activity, triggered by the body's stress response, drives much of this mortality by causing persistent tachycardia, increased myocardial oxygen consumption, reduced coronary perfusion, impaired cardiac output, endothelial dysfunction, and cellular metabolic derangements.
Beta-adrenergic blockers offer a physiologically plausible approach to counteract these harmful effects. A meta-analysis of 12 randomized controlled trials enrolling 1170 patients suggests beta-blockers may reduce 28-day mortality (risk ratio 0.76, 95% confidence interval 0.62-0.93). However, substantial heterogeneity exists across trials, with results ranging from a 44% mortality reduction to an 11% increase. One multicenter trial was stopped early for potential harm. This heterogeneity may be explained by inadvertent enrollment of patients at high risk of harm from beta-blockade: those with inadequate fluid resuscitation who depend on tachycardia to maintain cardiac output, and those with left or right ventricular dysfunction who cannot tolerate the negative inotropic effects of beta-blockers.
This pilot trial implements a predictive enrichment strategy using point-of-care ultrasound to exclude high-risk phenotypes before randomization. Eligible patients undergo POCUS assessment of fluid responsiveness using left ventricular outflow tract velocity time integral or carotid corrected flow time with passive leg raise. Patients demonstrating fluid responsiveness (greater than 15% change) are excluded as inadequately resuscitated. Cardiac function assessment excludes patients with moderate to severe left ventricular systolic dysfunction (ejection fraction less than 35%) or right ventricular dysfunction (tricuspid annular plane systolic excursion less than 17mm, severe RV dilation, septal shift, or RV S prime less than 9.5 cm/second).
Patients meeting eligibility criteria after POCUS screening are randomized 1:1 to esmolol or standard care. The intervention arm receives intravenous esmolol initiated at 50 mcg/kg/minute and titrated by 50 mcg/kg/minute every 15 minutes to achieve a target heart rate of 75-95 beats per minute, with a maximum dose of 300 mcg/kg/minute. Treatment continues for up to 5 days or until ICU discharge, death, or discontinuation of vasopressors for at least 6 hours. Both arms receive standard septic shock management per Surviving Sepsis Campaign guidelines.
Primary outcomes focus on feasibility: recruitment rate (target 4 patients per month), consent rate (target 80% or greater), POCUS screening completion rate (target 80% or greater), and protocol adherence (target 80% or greater). Secondary outcomes include 28-day and 90-day mortality, days alive and free of organ support therapies, and ICU and hospital length of stay.
- Conditions
- Septic Shock
- Being tested
- Esmolol
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Patients will receive an intravenous infusion of esmolol, an ultra-short-acting cardioselective beta-1 adrenergic receptor antagonist with a half-life of approximately 9 minutes. The infusion will be titrated to achieve a target heart rate of 75-95 beats per minute, with a maximum dose of 300 mcg/kg/minute. Treatment will continue for a maximum of 5 days or until ICU discharge, death, or resolution of shock (defined as discontinuation of vasopressors for at least 6 hours). Esmolol will be the preferred first-line treatment for tachyarrhythmias. All patients will continue to receive standard care for septic shock per Surviving Sepsis Campaign guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Patients randomized to this arm will receive standard care for septic shock according to Surviving Sepsis Campaign guidelines. This includes fluid resuscitation, a mean arterial pressure target of 65 mmHg or greater, early broad-spectrum antibiotics, source control when applicable, vasopressor support with norepinephrine as the first-line agent, stress-dose corticosteroids, early nutrition, and lung-protective mechanical ventilation when required. Beta-blockers and calcium channel blockers are prohibited throughout the 5-day study period. For patients who develop new-onset atrial fibrillation or flutter, amiodarone will be the preferred first-line antiarrhythmic agent. Treating physicians may use other antiarrhythmic medications at their discretion, provided they are not beta-blockers or calcium channel blockers. |
| Esmolol | Experimental | Patients will receive an intravenous infusion of esmolol, an ultra-short-acting cardioselective beta-1 adrenergic receptor antagonist with a half-life of approximately 9 minutes. The infusion will be titrated to achieve a target heart rate of 75-95 beats per minute, with a maximum dose of 300 mcg/kg/minute. Treatment will continue for a maximum of 5 days or until ICU discharge, death, or resolution of shock (defined as discontinuation of vasopressors for at least 6 hours). Esmolol will be the preferred first-line treatment for tachyarrhythmias. All patients will continue to receive standard care for septic shock per Surviving Sepsis Campaign guidelines. Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.
Measured: From study initiation to end of recruitment, approximately 25 months
Consent Rate
The total number of eligible participants consented divided by the total number of eligible participants approached for consent
Measured: From study initiation to end of recruitment, approximately 25 months
POCUS Screening Completion Rate
Number of participants who successfully underwent fluid responsiveness and cardiac function evaluation using point-of-care ultrasound, divided by the total number of participants eligible for POCUS screening. A successful POCUS entails acquiring adequate quality images for interpretation and providing conclusive assessments of fluid responsiveness, left ventricular function, and right ventricular function.
Measured: From study initiation to end of recruitment, approximately 25 months
Protocol Adherence
Intervention arm: The number of participants who received esmolol as per protocol divided by the total number of participants randomized to the intervention arm, and the total time spent within heart rate target divided by total time on esmolol infusion. Control arm: The number of participants who did not receive any beta-blocker therapy during the 5-day study period divided by the total number randomized to the control arm.
Measured: From day of randomization (day 1) to day 5
Secondary outcomes (5)
28-Day Mortality
Measured: From randomization to 28 days
90-Day Mortality
Measured: From randomization to 90 days
Duration of Mechanical Ventilation
Measured: From randomization to 28 days
Duration of Vasoactive Medications
Measured: From randomization to 28 days
Provision of Renal Replacement Therapy
Measured: From randomization to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Basmaji
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Western University, Canada
- Responsible party
- Sponsor-investigator, John Basmaji, Western University, Canada
- Investigators
- John Basmaji, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313605
- Sponsor's protocol ID
- 127880
- Acronym
- Epic-Beta
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McChesney C, Orozco N, Fiorini K, Wong MYS, Slessarev M, Prager R, Kao R, Leligdowicz A, Sharif S, Lewis K, Rochwerg B, Honarmand K, Ball IM, Arntfield R, Houlton R, VanNynatten L, Basmaji J. Impact of Short-Acting Beta-Blockers on the Outcomes of Patients With Septic Shock: A Systematic Review and Meta-Analysis. Crit Care Med. 2025 May 1;53(5):e1125-e1139. doi: 10.1097/CCM.0000000000006604. Epub 2025 Feb 26.
PubMed 40009025
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Blocker Therapy Versus Standard Care in Patients With Septic Shock: A Pilot Randomized Controlled Trial Utilizing Predictive Enrichment With Point-of-Care Ultrasound
- ClinicalTrials.gov ID
- NCT07313605
- Acronym / sponsor ID
- Epic-Beta / 127880
- Conditions
- Septic Shock
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- John BasmajiUniversity, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Western University, Canada
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 2 Jan 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.
The goal of this pilot clinical trial is to determine if conducting a larger study using point-of-care ultrasound (POCUS) to guide beta-blocker therapy in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure, requiring medications to support the heart and circulation. In septic shock, the body's stress response causes the heart to beat too fast, which can worsen organ damage.
Beta-blockers are medications that slow the heart rate and may improve outcomes, but previous studies have shown mixed results. Some patients may be harmed by beta-blockers if they have not received enough fluids or if their heart is not functioning well. This study uses ultrasound to identify patients who are most likely to benefit and least likely to be harmed by beta-blocker therapy.
The main questions this study aims to answer are: Is it feasible to recruit patients, obtain consent, perform ultrasound screening, and follow the study protocol? Researchers will compare two groups: one receiving the beta-blocker esmolol versus another receiving standard care, to assess the feasibility of a larger trial.
Participants in the esmolol group will receive an intravenous infusion titrated to achieve a target heart rate of 75-95 beats per minute for up to 5 days or until shock resolves. All participants will be monitored for 90 days to track survival and organ function.
Detailed description
Septic shock remains a leading cause of intensive care unit admissions and mortality worldwide, with approximately 50% of affected patients dying. Excess beta-adrenergic activity, triggered by the body's stress response, drives much of this mortality by causing persistent tachycardia, increased myocardial oxygen consumption, reduced coronary perfusion, impaired cardiac output, endothelial dysfunction, and cellular metabolic derangements.
Beta-adrenergic blockers offer a physiologically plausible approach to counteract these harmful effects. A meta-analysis of 12 randomized controlled trials enrolling 1170 patients suggests beta-blockers may reduce 28-day mortality (risk ratio 0.76, 95% confidence interval 0.62-0.93). However, substantial heterogeneity exists across trials, with results ranging from a 44% mortality reduction to an 11% increase. One multicenter trial was stopped early for potential harm. This heterogeneity may be explained by inadvertent enrollment of patients at high risk of harm from beta-blockade: those with inadequate fluid resuscitation who depend on tachycardia to maintain cardiac output, and those with left or right ventricular dysfunction who cannot tolerate the negative inotropic effects of beta-blockers.
This pilot trial implements a predictive enrichment strategy using point-of-care ultrasound to exclude high-risk phenotypes before randomization. Eligible patients undergo POCUS assessment of fluid responsiveness using left ventricular outflow tract velocity time integral or carotid corrected flow time with passive leg raise. Patients demonstrating fluid responsiveness (greater than 15% change) are excluded as inadequately resuscitated. Cardiac function assessment excludes patients with moderate to severe left ventricular systolic dysfunction (ejection fraction less than 35%) or right ventricular dysfunction (tricuspid annular plane systolic excursion less than 17mm, severe RV dilation, septal shift, or RV S prime less than 9.5 cm/second).
Patients meeting eligibility criteria after POCUS screening are randomized 1:1 to esmolol or standard care. The intervention arm receives intravenous esmolol initiated at 50 mcg/kg/minute and titrated by 50 mcg/kg/minute every 15 minutes to achieve a target heart rate of 75-95 beats per minute, with a maximum dose of 300 mcg/kg/minute. Treatment continues for up to 5 days or until ICU discharge, death, or discontinuation of vasopressors for at least 6 hours. Both arms receive standard septic shock management per Surviving Sepsis Campaign guidelines.
Primary outcomes focus on feasibility: recruitment rate (target 4 patients per month), consent rate (target 80% or greater), POCUS screening completion rate (target 80% or greater), and protocol adherence (target 80% or greater). Secondary outcomes include 28-day and 90-day mortality, days alive and free of organ support therapies, and ICU and hospital length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Patients randomized to this arm will receive standard care for septic shock according to Surviving Sepsis Campaign guidelines. This includes fluid resuscitation, a mean arterial pressure target of 65 mmHg or greater, early broad-spectrum antibiotics, source control when applicable, vasopressor support with norepinephrine as the first-line agent, stress-dose corticosteroids, early nutrition, and lung-protective mechanical ventilation when required. Beta-blockers and calcium channel blockers are prohibited throughout the 5-day study period. For patients who develop new-onset atrial fibrillation or flutter, amiodarone will be the preferred first-line antiarrhythmic agent. Treating physicians may use other antiarrhythmic medications at their discretion, provided they are not beta-blockers or calcium channel blockers. |
| Esmolol | Experimental | Drug: EsmololPatients will receive an intravenous infusion of esmolol, an ultra-short-acting cardioselective beta-1 adrenergic receptor antagonist with a half-life of approximately 9 minutes. The infusion will be titrated to achieve a target heart rate of 75-95 beats per minute, with a maximum dose of 300 mcg/kg/minute. Treatment will continue for a maximum of 5 days or until ICU discharge, death, or resolution of shock (defined as discontinuation of vasopressors for at least 6 hours). Esmolol will be the preferred first-line treatment for tachyarrhythmias. All patients will continue to receive standard care for septic shock per Surviving Sepsis Campaign guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Within 24 hours of diagnosis of septic shock based on Sepsis-3 criteria (requirement for vasopressors to maintain organ perfusion, lactate greater than 2 mmol/L, suspected or confirmed infection)
- Within 72 hours of ICU admission
- Tachycardia with heart rate 100 beats per minute or greater, defined as either sinus tachycardia or atrial fibrillation/flutter
Key exclusion criteria (10 listed)
- Known allergy to beta-blockers
- Second or third-degree heart block without a functioning pacemaker
- Acute bronchospasm or status asthmaticus
- Pregnancy
- Patient receiving extracorporeal membrane oxygenation
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 |
|---|---|---|
| EsmololPatients will receive an intravenous infusion of esmolol, an ultra-short-acting cardioselective beta-1 adrenergic receptor antagonist with a half-life of approximately 9 minutes. The infusion will be titrated to achieve a target heart rate of 75-95 beats per minute, with a maximum dose of 300 mcg/kg/minute. Treatment will continue for a maximum of 5 days or until ICU discharge, death, or resolution of shock (defined as discontinuation of vasopressors for at least 6 hours). Esmolol will be the preferred first-line treatment for tachyarrhythmias. All patients will continue to receive standard care for septic shock per Surviving Sepsis Campaign guidelines. | Drug | Esmolol |
Primary outcome
Recruitment Rate
Time frame: From study initiation to end of recruitment, approximately 25 months
Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.
Consent Rate
Time frame: From study initiation to end of recruitment, approximately 25 months
The total number of eligible participants consented divided by the total number of eligible participants approached for consent
POCUS Screening Completion Rate
Time frame: From study initiation to end of recruitment, approximately 25 months
Number of participants who successfully underwent fluid responsiveness and cardiac function evaluation using point-of-care ultrasound, divided by the total number of participants eligible for POCUS screening. A successful POCUS entails acquiring adequate quality images for interpretation and providing conclusive assessments of fluid responsiveness, left ventricular function, and right ventricular function.
Protocol Adherence
Time frame: From day of randomization (day 1) to day 5
Intervention arm: The number of participants who received esmolol as per protocol divided by the total number of participants randomized to the intervention arm, and the total time spent within heart rate target divided by total time on esmolol infusion. Control arm: The number of participants who did not receive any beta-blocker therapy during the 5-day study period divided by the total number randomized to the control arm.
5 secondary outcomes
28-Day Mortality
Time frame: From randomization to 28 days
90-Day Mortality
Time frame: From randomization to 90 days
Duration of Mechanical Ventilation
Time frame: From randomization to 28 days
Duration of Vasoactive Medications
Time frame: From randomization to 28 days
Provision of Renal Replacement Therapy
Time frame: From randomization to 28 days
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 6 Jan 2026.
- Results publication: PubMed 40009025McChesney C, Orozco N, Fiorini K, Wong MYS, Slessarev M, Prager R, Kao R, Leligdowicz A, Sharif S, Lewis K, Rochwerg B, Honarmand K, Ball IM, Arntfield R, Houlton R, VanNynatten L, Basmaji J. Impact of Short-Acting Beta-Blockers on the Outcomes of Patients With Septic Shock: A Systematic Review and Meta-Analysis. Crit Care Med. 2025 May 1;53(5):e1125-e1139. doi: 10.1097/CCM.0000000000006604. Epub 2025 Feb 26.
- Individual participant dataSharing planned: No
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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.
John Basmaji principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Esmolol in people with Septic Shock, run by John Basmaji.
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 4 inclusion and 10 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 John Basmaji Basmaji, MD (1-519-685-8500 Ext. 55661, john.basmaji@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From study initiation to end of recruitment, approximately 25 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07313605, which also lists 1 linked publication.
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 6 Jan 2026.