Esmolol to Control Adrenergic Storm in Septic Shock- ROLL-IN 2
(ECASSS-R2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen bySamuel M Brown, MD MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Samuel Brown

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Samuel M Brown, MD MS

Principal Investigator

Intermountain Health Care, Inc.

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years

Within 72 hours of admission to the ICU and septic shock (sepsis present at time of admission)

a. 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

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Treatment Details

Interventions

Esmolol (Beta Blocker)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: EsmololExperimental Treatment1 Intervention

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.