Phase 2
N=7
Esmolol Infusion for Patients With Septic Shock and Persistent Tachycardia
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT02841241 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Organ-failure-free Days — 26 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Esmolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intermountain Health Care, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Organ-failure-free Days |
26 | — |
| SECONDARY All-cause Mortality |
— | — |
| SECONDARY Peak Serum High-sensitivity Troponin |
0.14 | — |
| SECONDARY Left Ventricular Global Longitudinal Strain at 24 Hours |
-15.8 | — |
| SECONDARY Development of Heart Block |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 ( 200 msec
- Current evidence or prior history of Grade 2 or Grade 3 heart block
- Pacemaker or plans to place a pacemaker
- Pheochromocytoma or status asthmaticus
- Receiving clonidine, guanfacine, or moxonidine
- Hemoglobin < 7 gm/dl
- Cardiovascular collapse (failure to achieve MAP of 65mmHg)
- Cardiac arrest within 24 hours
- Worse than moderate aortic stenosis
- Known aortic stenosis, with any of (1) mean gradient ≥ 40 mmHg OR (2) maximum gradient ≥ 60mmHg OR (3) aortic valve area ≤ 1.0cm2 OR (4) aortic valve area index ≤ 0.85cm2/m2 body surface area.
- Worse than mild mitral stenosis • Known mitral stenosis, with any of (1) valve area ≤ 1.5 cm2 OR mean gradient ≥ 5 mmHg.
Data sourced from ClinicalTrials.gov (NCT02841241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.