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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188888
• Other study ID #: 2309
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: August 6, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• septic shock criteria

• presence of heart rate > 95 bpm.

Exclusion Criteria:

• Pregnancy

• age < 18

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Anesthesiology and Intensive care of the University of Rome La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	arterial pressure waveform	systolic, diastolic and dicrotic pressures	over a period of four hours	No
Primary	heart rate		over a period of four hours	No
Secondary	echocardiography	LV ejection fraction (LVEF) and tricuspidal annular plane solid excursion (TAPSE)	over a period of four hours	No
Secondary	static arterial elastance		over a period of four hours	No