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

NCT02188888 | Completed

• 1 other identifier: 2309
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachycardia; Septic Shock

Keywords

septic shock; esmolol; tachycardia; betablockers

Outcome Measures

Primary Outcomes (1)

• heart rate

  over a period of four hours

Secondary Outcomes (2)

• echocardiography

  over a period of four hours

• static arterial elastance

  over a period of four hours

Other Outcomes (1)

• arterial pressure waveform

  over a period of four hours

Study Arms (1)

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

Interventions

esmolol DRUG

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

Tachycardic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy
• age \< 18

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

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

Rome, 00161, Italy

Location

Related Publications (1)

• 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.

  PMID: 32690246 DERIVED

MeSH Terms

Conditions

Tachycardia; Shock, Septic

Interventions

esmolol

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Morelli, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

IT (1)