Septic ShockPhase 2ECASSS-R2NCT03208257
Esmolol to Control Adrenergic Storm in Septic Shock- ROLL-IN 2
A Phase 2 study testing Esmolol in people with Septic Shock, run by Samuel Brown at 1 site in United States.
Trial summary
Septic shock is a common syndrome caused by the body's response to an infection. Septic shock is responsible for 10% of all ICU admissions and 30% of ICU deaths. Use of "beta blocker" medications may improve outcomes after septic shock. 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 72 hours of admission to the ICU and septic shock (sepsis present at time of admission)
- Septic shock defined by SEPSIS-3 consensus criteria as i. Suspected or documented infection ii. Sequential Organ Failure Assessment (SOFA) score increased by at least 2 points over baseline iii. Lactate > 2mmol/L iv. 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.
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- 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]).
- Inferior vena cava (IVC) plethora
- For patients who happen to be breathing passively (i.e., paralyzed or deeply sedated) on a positive pressure mechanical ventilator delivering at least 8 ml/kg tidal volumes and in normal sinus rhythm, stroke volume variability <13% (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 ExtraCorporeal Membrane Oxygenation (ECMO).
- 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.
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- Previously enrolled in the trial.
- Known allergy to esmolol or vehicle (see Appendix 2 for BREVIBLOC vehicle ingredients).
- Receipt of nodal blocking agents (see Appendix 3 for list of such 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 transthoracic echocardiogram (TTE) of any of the following
- Mean Pulmonary Arterial Pressure (mPAP) ≥ 35mmHg (millimeters of mercury)
- Systolic Pulmonary Arterial Pressure (SPAP) ≥ 60mmHg (millimeters of mercury)
- Cardiovascular collapse, as manifested by inability to achieve a mean arterial pressure (MAP) of 65 mmHg with vasopressor therapy.
- Cardiogenic shock, as defined by any of the following
- Cardiac index ≤ 2.3 L/min/m2
- Ejection fraction ≤ 30%
- ScvO2 ≤ 60%
- Current infusion of any dose of dobutamine, milrinone, or dopamine (if dopamine is being used for clinically diagnosed bradycardia or cardiogenic shock)
- Current infusion of epinephrine for clinically diagnosed cardiogenic shock
- Significant atrioventricular dysfunction
- Sick sinus syndrome
- PR interval > 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
- 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, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Valerie T Aston, MBA, 801-507-4606, valerie.aston@imail.org
David P Tomer, MS, (801) 507-4694, David.Tomer@imail.org
About this study
Septic shock is a common syndrome caused by the body's response to an infection. Septic shock is responsible for 10% of all ICU admissions and 30% of ICU deaths. Use of "beta blocker" medications may improve outcomes after septic shock. This pilot study evaluates protocols to infuse the beta blocker esmolol in patients with septic shock.
Read the detailed description
This is a prospective, single arm, feasibility study of esmolol infusion in septic shock. The objective is to evaluate the feasibility, adequacy, and efficiency of study protocols for a subsequent ECASSS study. This study (ECASSS-R2) extends observations made in an initial pilot, ECASSS-R.
- 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 hydrochloride infusion
| Study group | Role | What they receive |
|---|---|---|
| Esmolol | Experimental | Intravenous esmolol will be administered as a continuous infusion according to protocol to control tachycardia with maximal infusion rates in the range of 10-40 mcg/kg/min. Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ-failure-free days
Measured: 28 days
Secondary outcomes (5)
All-cause hospital mortality
Measured: During hospitalization
All-cause 28-day and 90-day mortality
Measured: 28 days and 90 days
Peak serum high-sensitivity troponin
Measured: 24 hours
Left ventricular (LV) longitudinal strain
Measured: 24 hours
ICU-free days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start7 Aug 2017
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Brown
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor-investigator, Samuel Brown, Intermountain Health Care, Inc.
- Investigators
- Samuel M Brown, MD MS, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208257
- Sponsor's protocol ID
- 1050522
- Acronym
- ECASSS-R2
- Status last verified
- Feb 2019
- First submitted
- 2 Jul 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esmolol to Control Adrenergic Storm in Septic Shock- ROLL-IN 2
- ClinicalTrials.gov ID
- NCT03208257
- Acronym / sponsor ID
- ECASSS-R2 / 1050522
- Conditions
- Septic Shock
- Keywords
- esmolol, adrenergic storm, septic shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Samuel BrownUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Septic shock is a common syndrome caused by the body's response to an infection. Septic shock is responsible for 10% of all ICU admissions and 30% of ICU deaths. Use of "beta blocker" medications may improve outcomes after septic shock. This pilot study evaluates protocols to infuse the beta blocker esmolol in patients with septic shock.
Detailed description
This is a prospective, single arm, feasibility study of esmolol infusion in septic shock. The objective is to evaluate the feasibility, adequacy, and efficiency of study protocols for a subsequent ECASSS study. This study (ECASSS-R2) extends observations made in an initial pilot, ECASSS-R.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esmolol | Experimental | Drug: EsmololIntravenous esmolol will be administered as a continuous infusion according to protocol to control tachycardia with maximal infusion rates in the range of 10-40 mcg/kg/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Within 72 hours of admission to the ICU and septic shock (sepsis present at time of admission)
- 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.
Key exclusion criteria (32 listed)
- Lack of informed consent.
- Currently receiving ExtraCorporeal Membrane Oxygenation (ECMO).
- Known pregnancy or nursing.
- Patient is a prisoner.
- Patient on hospice (or equivalent comfort care approach) at or before the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsmololAlso: BREVIBLOCEsmolol hydrochloride infusion | Drug | Esmolol |
Primary outcome
Organ-failure-free days
Time frame: 28 days
5 secondary outcomes
All-cause hospital mortality
Time frame: During hospitalization
All-cause 28-day and 90-day mortality
Time frame: 28 days and 90 days
Peak serum high-sensitivity troponin
Time frame: 24 hours
Left ventricular (LV) longitudinal strain
Time frame: 24 hours
ICU-free days
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Yes. In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel M Brown, MD MS principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esmolol in people with Septic Shock, run by Samuel Brown 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 12 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 26 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie T Aston, MBA ((801) 507-4606, valerie.aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ-failure-free days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2019.