Clinical trial NCT07313605: POCUS-Guided Esmolol in Septic Shock: A Pilot RCT
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
Conditions: Septic Shock
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. 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.
Interventions:
description: 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.
name: Esmolol
type: Drug
Study arms:
design_group_description: 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.
design_group_title: Standard Care
design_group_type: No Intervention
design_group_description: 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.
design_group_title: Esmolol
design_group_type: Experimental
Sponsor: University of Western Ontario
Collaborators: University of Western Ontario
Drug name mappings:
name: 盐酸艾司洛尔
lang: CN
name: Esmolol Hydrochloride
lang: EN
name: エスモロール塩酸塩
lang: JP