Esmolol to Treat the Hemodynamic Effects of Septic Shock

• Status: Terminated
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: American Heart Association
• Treatments: Esmolol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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