AzTrials
AzTrials

Septic ShockPhase 2ECASSS-RNCT02841241

Esmolol Infusion for Patients With Septic Shock and Persistent Tachycardia

A Phase 2 study testing Esmolol in people with Septic Shock, run by Intermountain Health Care, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
Esmolol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Apr 2016to Mar 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Within 48 hours of admission to the ICU and septic shock (sepsis present at time of admission)
  • 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.
Show all 11Show fewer
  • 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).

Who cannot join

  • 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.
Show all 34Show fewer
  • 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
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Intermountain Medical Center and Intermountain Clinics

    Murray, Utah, 84143

Other trials in United States

About this study

Official title: Esmolol to Control Adrenergic Storm in Septic Shock - Roll-in

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.

Read the detailed description

PRIMARY OBJECTIVE:

To evaluate the adequacy and efficiency of study protocols for the anticipated, randomized, controlled ECASSS study. The primary clinical outcome is organ-failure free days at 28 days, with multiple secondary outcomes, including those relevant to function of and compliance with the study protocols.

Conditions
Septic Shock
Being tested
Esmolol
Keywords
esmolol, adrenergic storm, septic shock
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsmololDrug

    Also called Brevibloc

    Esmolol infusion

Study groups in NCT02841241
Study groupRoleWhat they receive
EsmololExperimentalEsmolol infusion, started without bolus, with slow upward titration to a maximum infusion rate is protocolized, with a target heart rate of 80-90/min
Receives: Drug: Esmolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Organ-failure-free Days

    As of day 28, the number of calendar days on which the patient receives none of (a) vasopressor therapy, (b) mechanical ventilation, or (c) renal replacement therapy. If the patients dies on or before day 28, they have -1 organ-failure-free days.

    The resulting point-based score combines the probability of death and the number of days without organ failure.

    Score of -1 = Death before day 28 (Lowest Score). Score of 28 = Patient has been successful at going 28 without any vasopressor therapy/mechanical ventilation/renal replacement therapy (Highest Score)

    Measured: Day 28

Secondary outcomes (4)

  1. All-cause Mortality

    Measured: 90 days

  2. Peak Serum High-sensitivity Troponin

    Measured after enrollment.

    Measured: Troponin is measured on day 0 and day 1 (first day of esmolol infusion is day 0)

  3. Left Ventricular Global Longitudinal Strain at 24 Hours

    Measured: Day 1

  4. Development of Heart Block

    Measured: for duration of esmolol infusion, an expected average of 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02841241
Sponsor's protocol ID
1050147
Acronym
ECASSS-R
Status last verified
Dec 2018
First submitted
14 Jul 2016
Last updated
9 Jan 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Rudiger A, Singer M. The heart in sepsis: from basic mechanisms to clinical management. Curr Vasc Pharmacol. 2013 Mar 1;11(2):187-95.

    PubMed 23506497

  • Novotny NM, Lahm T, Markel TA, Crisostomo PR, Wang M, Wang Y, Ray R, Tan J, Al-Azzawi D, Meldrum DR. beta-Blockers in sepsis: reexamining the evidence. Shock. 2009 Feb;31(2):113-9. doi: 10.1097/SHK.0b013e318180ffb6.

    PubMed 18636043

  • Oberbeck R, Kobbe P. Beta-adrenergic antagonists: indications and potential immunomodulatory side effects in the critically ill. Curr Med Chem. 2009;16(9):1082-90. doi: 10.2174/092986709787581770.

    PubMed 19275613

  • Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D'Egidio A, D'Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M. Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1683-91. doi: 10.1001/jama.2013.278477.

    PubMed 24108526

  • Brown SM, Beesley SJ, Lanspa MJ, Grissom CK, Wilson EL, Parikh SM, Sarge T, Talmor D, Banner-Goodspeed V, Novack V, Thompson BT, Shahul S; Esmolol to Control Adrenergic Storm in Septic Shock-ROLL-IN (ECASSS-R) study. Esmolol infusion in patients with septic shock and tachycardia: a prospective, single-arm, feasibility study. Pilot Feasibility Stud. 2018 Aug 3;4:132. doi: 10.1186/s40814-018-0321-5. eCollection 2018.

    PubMed 30123523

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Esmolol in people with Septic Shock, run by Intermountain Health Care, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ-failure-free Days (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02841241, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in