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

August 6, 2015 updated by: Andrea Morelli, University of Roma La Sapienza

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00161
        • Department of Anesthesiology and Intensive care of the University of Rome La Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • age < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
heart rate
Time Frame: over a period of four hours
over a period of four hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
echocardiography
Time Frame: over a period of four hours
LV ejection fraction (LVEF) and tricuspidal annular plane solid excursion (TAPSE)
over a period of four hours
static arterial elastance
Time Frame: over a period of four hours
over a period of four hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial pressure waveform
Time Frame: over a period of four hours
systolic, diastolic and dicrotic pressures
over a period of four hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Septic Shock

Clinical Trials on esmolol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe