[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"critical-illness-sepsis-severe\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:critical-illness-sepsis-severe":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641364","effects-of-esmolol-on-sublingual-microcirculation-and-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100641364",false,"NCT07657754","Effects of Esmolol on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock","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","Inclusion Criteria:\n\nAge 18-85 years. Diagnosis of septic shock according to Sepsis-3 criteria, requiring norepinephrine to maintain MAP ≥65 mmHg after adequate fluid resuscitation.\n\nPersistent tachycardia after initial hemodynamic optimization, adequate analgesia\u002Fsedation, and correction of reversible causes, defined as heart rate ≥95 beats\u002Fmin.\n\nContinuous norepinephrine infusion for ≥6 hours, with norepinephrine dose ≥0.10 μg\u002Fkg\u002Fmin at enrollment.\n\nAdequate volume status or absence of fluid responsiveness assessed by dynamic indices, echocardiography, or advanced hemodynamic monitoring; if PiCCO is used, GEDVI \\>700 mL\u002Fm² and\u002For ITBVI \\>850 mL\u002Fm² may be used as supportive criteria.\n\nPreserved or hyperdynamic cardiac function before esmolol initiation, defined as cardiac index \\>3.0 L\u002Fmin\u002Fm² or absence of severe septic cardiomyopathy.\n\nAbility to obtain sublingual microcirculatory images of acceptable quality at baseline.\n\nWritten informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\nShock mainly caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n\nSevere cardiac dysfunction or severe septic cardiomyopathy, including cardiac index \\\u003C2.2 L\u002Fmin\u002Fm² despite adequate preload, severe ventricular dysfunction, or need for inotropic agents at enrollment.\n\nUse 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\u002Fasthma, or known allergy to esmolol.\n\nSevere 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.\n\nAcute coronary syndrome, life-threatening arrhythmia, or cardiac arrest before enrollment during the current ICU stay.\n\nConditions interfering with sublingual microcirculatory assessment, including major oral\u002Fsublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n\nPregnancy or lactation, expected death or withdrawal of life-sustaining treatment within 24 hours, expected ICU stay \\\u003C48 hours, or inability to obtain informed consent.","ALL","18 Years","85 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nApproximately 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.\n\nThe 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.",[27,28,29],"Septic Shock","Sepsis","Critical Illness Sepsis, Severe",[31,32,33,34,35,36,27],"esmolol","sublingual microcirculation","microvascular flow index","critical closing pressure","mean systemic filling pressure","vascular waterfall","NOT_YET_RECRUITING","2026-06-14",{"date":40,"type":41},"2026-06-18","ACTUAL",{"date":43,"type":21},"2026-08-01",{"date":45,"type":21},"2027-12-30",{"name":47,"class":48},"First Affiliated Hospital of Wannan Medical College","OTHER",2]