Clinical trial NCT02188888: Echocardiographic and Arterial Pressure Waveform Changes After Reducing Heart Rate With Esmolol in Septic Shock Patients
Official title: Heart Rate Reduction With Esmolol is Associated With Improved Arterial Elastance in Patients With Septic Shock. A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachycardia
Septic Shock
Keywords: septic shock
esmolol
tachycardia
betablockers
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Septic shock patients with heart rate \> of 95 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) between 65 and 75 mmHg after at least 24 hours of hemodynamic optimization.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy
* age \< 18

Primary outcomes:
measure: heart rate
timeFrame: over a period of four hours
Secondary outcomes:
measure: echocardiography
timeFrame: over a period of four hours
measure: static arterial elastance
timeFrame: over a period of four hours
Other outcomes:
measure: arterial pressure waveform
timeFrame: over a period of four hours
Locations:
city: Rome
country: Italy
facility: Department of Anesthesiology and Intensive care of the University of Rome La Sapienza
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morelli A, Romano SM, Sanfilippo F, Santonocito C, Frati G, Chiostri M, Agro FE, Ertmer C, Rehberg SW, Vieillard-Baron A. Systolic-dicrotic notch pressure difference can identify tachycardic patients with septic shock at risk of cardiovascular decompensation following pharmacological heart rate reduction. Br J Anaesth. 2020 Dec;125(6):1018-1024. doi: 10.1016/j.bja.2020.05.058. Epub 2020 Jul 18.