Esmolol Infusion for Patients With Septic Shock and Persistent Tachycardia

Completed · Phase 2

Conditions studied: Septic Shock

In brief

This is a prospective, single arm, "roll-in" study of esmolol infusion for patients with septic shock with persistent tachycardia after adequate intravenous volume expansion. The study will evaluate the adequacy and efficiency of study protocols for the anticipated, main ECASSS study, which will have a separate entry in clinicaltrials.gov.

Key facts

Study ID: NCT02841241
Run by: Intermountain Health Care, Inc.
People needed: 7
Starts: 2016-04-01
Expected to finish: 2017-03-01
Last updated by the study team: 2019-01-09

Who can join

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

You may qualify if…

Age ≥ 18 years
Within 48 hours of admission to the ICU and septic shock (sepsis present at time of admission)
a. Septic shock defined by consensus criteria as i. At least two systemic inflammatory response syndrome (SIRS) criteria ii. Suspected or documented infection iii. Receiving vasopressors to treat hypotension after at least 20 ml/kg intravenous crystalloid volume expansion
Receiving vasopressors through a central venous catheter for more than 60 minutes.
Arterial catheter in place or expected to be placed imminently.
Heart rate > 90/min while receiving vasopressors for more than 60 minutes.
Adequately volume expanded, as manifest by any of the following, performed as part of routine clinical care (i.e., no study procedures will be performed before signed consent). If none of these measures are clinically available, the clinical attending must confirm that volume expansion is adequate. (After enrollment, a final safety check will confirm the adequacy of volume expansion.)
Central venous pressure (CVP) > 15 mm Hg.
Negative Passive-Leg Raise (PLR) maneuver (<10% increase in cardiac output after PLR).
No cardiac output response (<10% increase) after rapid infusion (<5 min) of 250 ml of IV crystalloid, i.e., a graded volume expansion challenge (GVEC).
For patients who happen to be breathing passively on a positive pressure mechanical ventilator delivering at least 8 ml/kg tidal volumes and in normal sinus rhythm, stroke volume variability <10% (such patients are acknowledged to be uncommon; the protocol does not recommend or require the induction of passive breathing).

You may not qualify if…

Lack of informed consent.
Currently receiving ECMO (extracorporeal membrane oxygenation).
Known pregnancy or nursing.
Patient is a prisoner.
Patient on hospice (or equivalent comfort care approach) at or before the time of enrollment.
Known or current atrial fibrillation.
Previously enrolled in the trial.
Known allergy to esmolol or vehicle
Receipt of nodal blocking agents within three half lives
Hemoglobin < 7 gm/dl.
Cardiac arrest within 24 hours.
Pulmonary hypertension (moderate or severe), from documented history of prior right heart catheterization or current evidence on TTE (transthoracic echocardiography) of any of the following
mPAP (mean pulmonary artery pressure) ≥ 35 mmHg
SPAP (systolic pulmonary artery pressure)≥ 60 mmHg
Cardiovascular collapse, as manifested by inability to achieve a MAP (mean arterial pressure) of 65 mmHg with vasopressor therapy.
Cardiogenic shock, as defined by any of the following
Cardiac index ≤ 2 L/min/m2
Ejection fraction ≤ 25%
ScvO2 ≤ 60%
Current infusion of any dose of dobutamine, milrinone, or dopamine
Current infusion of epinephrine for clinically diagnosed cardiogenic shock
Significant atrioventricular dysfunction
Sick sinus syndrome
PR interval (time from onset of P wave to start of QRS complex) > 200 msec
Current evidence or prior history of Grade 2 or Grade 3 heart block

Where it is running

Intermountain Medical Center and Intermountain Clinics — Murray, Utah, United States

Full record on ClinicalTrials.gov

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