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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Shock, Septic

Treatments: Drug: Esmolol

Study type: Interventional

Funder types: Other

Identifiers

NCT02842983

esmolol sepsis

Details and patient eligibility

About

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.

Full description

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Esmolol

Experimental group

Description:

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.

Treatment:

Drug: Esmolol

Control

No Intervention group

Description:

Patients received conventional management of septic shock