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Echocardiographic and Arterial Pressure Waveform Changes After Reducing Heart Rate With Esmolol in Septic Shock Patients

Heart Rate Reduction With Esmolol is Associated With Improved Arterial Elastance in Patients With Septic Shock. A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02188888
Enrollment
45
Registered
2014-07-14
Start date
2013-12-31
Completion date
2014-06-30
Last updated
2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock, Tachycardia

Keywords

septic shock, esmolol, tachycardia, betablockers

Brief summary

Clinical study suggests that beta-blockers by decreasing heart rate together with an increase in stroke volume do not negatively affect cardiac output allowing an economization of cardiac work and oxygen consumption in patients with septic shock. Whether this hemodynamic profile leads to an amelioration of myocardial performance is still unclear. The objective of the present study is therefore to elucidate whether a reduction in heart rate with esmolol is associated to an improvement of cardiac efficiency in patients with septic shock who remained tachycardic after hemodynamic optimization.

Detailed description

After 24-36 hours of initial hemodynamic stabilization, 44 septic shock patients with heart rate \> of 95 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation,will receive a continuous esmolol infusion to maintain heart rate between 94 and 80 bpm. Norepinephrine will be titrated to achieve a MAP between 65 and 75 mmHg. To investigate myocardial performance, we will simultaneously assess LV ejection fraction (LVEF), tricuspidal annular plane solid excursion (TAPSE) by echocardiography, the dP/dt MAX and the cardiac cycle efficiency (CCE) both estimated from the arterial pressure waveform. Finally we will analyze changes in static arterial elastance. Data will be obtained at baseline and after four hours once achieved the predefined heart rate threshold.

Interventions

DRUGesmolol

Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* septic shock criteria * presence of heart rate \> 95 bpm.

Exclusion criteria

* Pregnancy * age \< 18

Design outcomes

Primary

MeasureTime frame
heart rateover a period of four hours

Secondary

MeasureTime frameDescription
echocardiographyover a period of four hoursLV ejection fraction (LVEF) and tricuspidal annular plane solid excursion (TAPSE)
static arterial elastanceover a period of four hours

Other

MeasureTime frameDescription
arterial pressure waveformover a period of four hourssystolic, diastolic and dicrotic pressures

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026