Esmolol to Treat the Hemodynamic Effects of Septic Shock

Stopped early · Phase 2

Conditions studied: Septic Shock, Hypotension, Tachycardia

In brief

The main purpose of this study is to determine the effects of controlling the heart rate of patients with septic shock using an intravenous medication called esmolol.

Key facts

Study ID

NCT02369900

Run by

Beth Israel Deaconess Medical Center

People needed

40

Starts

2015-03-01

Expected to finish

2019-12-31

Last updated by the study team

2021-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (≥ 18 years)
• Sepsis defined as suspected or confirmed infection with at least two systemic inflammatory response syndrome (SIRS) criteria
• Norepinephrine (minimum 0.1 mcg/kg/min) support to maintain a mean arterial pressure ≥ 65 mmHg despite appropriate volume resuscitation (as defined by the clinical team, however at least 30mL/kg intravenous fluid
• Heart rate ≥ 95 per minute for at least 2 hours prior to enrollment
• 6-24 hours since ICU admission

You may not qualify if…

• Intravenous β-blocker therapy prior to randomization
• Pronounced cardiac dysfunction (i.e. cardiac index [CI] ≤ 2.2 L/min/m2)
• Known significant valvular heart disease
• Research-protected populations (pregnant women, prisoners, intellectually disabled)
• Known "Do-not-resuscitate" or "do-not-intubate" order at the time of enrollment
• Infusion of epinephrine, dopamine, dobutamine or milrinone at time of enrollment
• Known allergy/sensitivity to esmolol or history of asthma/COPD

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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