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

Phase 2

• Conditions: Shock, Septic
• Interventions: Drug: Esmolol

• Registration Number: NCT02842983
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2014-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-22
• Last Update Submitted: 2016-07-22
• Study First Posted: 2016-07-25
• Last Update Posted: 2016-07-25
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esmolol	Esmolol	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.

Primary Outcome Measures

Name	Time	Method
Echocardiographic assessment of heart function	over a period of 72 hrs	peak systolic velocity measured at the mitral annulus decreased 30% compared with control group

Secondary Outcome Measures

Name	Time	Method
Effects on vasopressor requirement	over a period of 72 hrs	Dosage of norepinephrine increased 100% compared with control group
90-day hospital mortality	90 days

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China