Echocardiographic and Arterial Pressure Waveform Changes After Reducing Heart Rate With Esmolol in Septic Shock Patients
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| ClinicalTrials.gov Identifier: NCT02188888 |
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Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : August 7, 2015
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Sponsor:
University of Roma La Sapienza
Information provided by (Responsible Party):
Andrea Morelli, University of Roma La Sapienza
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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 |
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 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: esmolol
Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm |
Primary Outcome Measures :
- heart rate [ Time Frame: over a period of four hours ]
Secondary Outcome Measures :
- echocardiography [ Time Frame: over a period of four hours ]LV ejection fraction (LVEF) and tricuspidal annular plane solid excursion (TAPSE)
- static arterial elastance [ Time Frame: over a period of four hours ]
Other Outcome Measures:
- arterial pressure waveform [ Time Frame: over a period of four hours ]systolic, diastolic and dicrotic pressures
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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
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
| 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
| Principal Investigator: | Andrea Morelli, MD | University of Roma La Sapienza |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |