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Completed

NCT Number: NCT02188888

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

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.

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Key information

Conditions

Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive care of the University of Rome La Sapienza

Rome, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • septic shock criteria
  • presence of heart rate > 95 bpm.

Exclusion criteria

  • Pregnancy
  • age < 18

Treatment and study plan

esmolol

Drug

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

Primary outcomes

  1. heart rate

    Time frame: over a period of four hours

Secondary outcomes

  1. echocardiography

    Time frame: over a period of four hours

    LV ejection fraction (LVEF) and tricuspidal annular plane solid excursion (TAPSE)

  2. static arterial elastance

    Time frame: over a period of four hours

Other outcomes

  1. arterial pressure waveform

    Time frame: over a period of four hours

    systolic, diastolic and dicrotic pressures

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2014
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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