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Clinical Trials/NCT02842983
NCT02842983
Unknown
Phase 2

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

Peking Union Medical College Hospital1 site in 1 country36 target enrollmentDecember 2014
ConditionsShock, Septic
InterventionsEsmolol
DrugsEsmolol

Overview

Phase
Phase 2
Intervention
Esmolol
Conditions
Shock, Septic
Sponsor
Peking Union Medical College Hospital
Enrollment
36
Locations
1
Primary Endpoint
Echocardiographic assessment of heart function
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Esmolol

Outcomes

Primary Outcomes

Echocardiographic assessment of heart function

Time Frame: over a period of 72 hrs

peak systolic velocity measured at the mitral annulus decreased 30% compared with control group

Secondary Outcomes

  • Effects on vasopressor requirement(over a period of 72 hrs)
  • 90-day hospital mortality(90 days)

Study Sites (1)

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