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

NCT ID: NCT02188888

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-06-30

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.

Conditions

Tachycardia; Septic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

esmolol

Intervention Type: DRUG

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

Interventions

esmolol

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• age < 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Andrea Morelli

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32690246 (View on PubMed)

Other Identifiers

2309

Identifier Type: -

Identifier Source: org_study_id