CompletedPhase 2

Esmolol in Sepsis Management:Evaluating Immunomodulatory Effects and Impact on Patient Outcomes

China150 participantsStarted 2021-01-01

Plain-language summary

Evaluate the effectiveness of esmolol, a selective β1-adrenergic receptor blocker, in modulating immune responses and improving patient outcomes in sepsis.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Patients aged between 18 and 90 years.
✓. Diagnosed with sepsis or septic shock according to the diagnostic criteria in Suivival Sepsis of 2021.
✓. Received adequate fluid resuscitation and necessary exogenous Norepinephrine (NE).
✓. No contraindications to Esmolol and appropriate heart rate levels determined by clinical assessment.
✓. Provided written informed consent.

Exclusion criteria

✕. Deceased within three days following ICU admission.
✕. Pregnant or lactating individuals.
✕. Underwent surgical procedures within the last two weeks.
✕. Severe cardiac failure exceeding NYHA Class III.
✕. Usage of long-term oral β-blockers or any form of extracorporeal circulation within the last two weeks.
✕. Presenting with sinus bradycardia or atrioventricular block.
✕. Received high doses of corticosteroids in the past three months.
✕. Underwent significant hormone therapy, persistent blood loss of more than 500 ml within any 24-hour period, or were treated with Esmolol for less than three days.

What they're measuring

Impact of Esmolol on Survival Rates

Timeframe: Survival rates will be monitored from the time of randomization until the end of the study period or until patient death, whichever comes first, up to 28 days post-randomization.

Improvement in Organ Function and Inflammatory Markers

Timeframe: Organ function and inflammatory markers will be measured at baseline, then regularly throughout the patient's stay in the ICU, up to a maximum of 28 days.

Trial details

NCT IDNCT06390748

SponsorLin Chen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Sepsis trials