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

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ClinicalTrials.gov Identifier: NCT02188888
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Andrea Morelli, University of Roma La Sapienza

Study Description
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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.

Condition or disease Intervention/treatment
Tachycardia Septic Shock Drug: esmolol

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.
Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Rate Reduction With Esmolol is Associated With Improved Arterial Elastance in Patients With Septic Shock. A Prospective Observational Study
Study Start Date : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Group/Cohort Intervention/treatment
Tachycardic patients
Patients 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.
 Drug: esmolol
Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm


Outcome Measures
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Primary Outcome Measures :
  1. heart rate [ Time Frame: over a period of four hours ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. arterial pressure waveform [ Time Frame: over a period of four hours ]
    systolic, diastolic and dicrotic pressures


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • age < 18
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188888


Locations
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Italy
Department of Anesthesiology and Intensive care of the University of Rome La Sapienza
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Andrea Morelli, MD University of Roma La Sapienza
More Information
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Responsible Party: Andrea Morelli, associate professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02188888    
Other Study ID Numbers: 2309
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by Andrea Morelli, University of Roma La Sapienza:
septic shock
esmolol
tachycardia
betablockers
Additional relevant MeSH terms:
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Shock, Septic
Tachycardia
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs