Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

Study Overview
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Brief Summary
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After initial hemodynamic stabilization, 36 septic shock patients with heart rate > of 90 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will be randomised into two groups, esmolol group and control group. Patients allocated to esmolol group will receive a continuous esmolol infusion to maintain a lowering of heart rate of 10%. Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To investigate myocardial performance, the investigators will assess Tissue Doppler imaging by echocardiography and hemodynamic measures. Data will be obtained at baseline ,after esmolol infusion once achieved the predefined heart rate threshold and 72hours after esmolol infusion.

Detailed Description
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primary outcome were determined according to our previous study of tissue doppler.

Official Title
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Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

Conditions
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Shock, Septic

Intervention / Treatment
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* Drug: Esmolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: septic shock fluid optimization with a cardiac index > 3 l/min/m2 Heart Rate >90 /min Exclusion Criteria: Cardiogenic shock Bradycardia History of Severe Asthma Indications against Esmolol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esmolol<br>After, at least six hours of hemodynamic optimization, patients with a hyperdynamic shock received a conventional management with a continuous infusion of Esmolol titrated to gain a 10% reduction in heart rate. This infusion is maintained for 72 hours. | Drug: Esmolol<br>* conventional management plus esmolol infusion<br>* Other names: beta blockers;|
| No Intervention: Control<br>Patients received conventional management of septic shock | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic assessment of heart function | peak systolic velocity measured at the mitral annulus decreased 30% compared with control group | over a period of 72 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on vasopressor requirement | Dosage of norepinephrine increased 100% compared with control group | over a period of 72 hrs | 
| 90-day hospital mortality |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esmolol, Hypotension, Shock, Septic, Sepsis, Systemic Inflammatory Response Syndrome, Adrenergic beta-1 Receptor Antagonists, Adrenergic Antagonists, Pharmacologic Actions, Physiological Effects of Drugs