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NCT Number: NCT06390748

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

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

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Key information

Conditions

Sepsis Autonomic Nervous System Diseases Beta-Blocker Catecholamine; Overproduction Cytokine Release Syndrome Cytokine Storm Immunologic Paralysis Infections Inflammation Lymphocyte Disorder T Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Sympathetic Nervous System Diseases Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610091, China

About this study

The research aimed to investigate the immunomodulatory effects of Esmolol in sepsis treatment. A comprehensive study was conducted, incorporating both direct experimental assays and data extraction from Electronic Health Records (EHR) to evaluate physiological and immunological responses in septic patients. Specifically, Norepinephrine (NE) levels were measured, and CD4+/CD8+ T cells were quantified to assess changes influenced by Esmolol administration. Additionally, cytokine profiles, Procalcitonin (PCT) levels, complete blood counts (CBC), and routine biochemical functions were monitored through data retrieved from EHR systems, providing a broad perspective on patient health and response to treatment. This multifaceted approach aimed to determine how Esmolol affects key immune parameters and overall patient outcomes, addressing both the direct and systemic impacts of this treatment on septic patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

esmolol

Drug

The primary intervention is the administration of Esmolol. Esmolol was specifically used to evaluate its immunomodulatory effects in patients with sepsis in the study. The dosage was tailored to achieve optimal heart rate control, an integral part of the therapeutic strategy aiming to mitigate the hyperadrenergic state often seen in sepsis. Alongside Esmolol, daily electrocardiogram (ECG) monitoring was incorporated to observe any changes in the QT interval, ensuring cardiac safety due to the known potential cardiac effects of beta-blockers.

Primary outcomes

  1. Impact of Esmolol on Survival Rates

    Time frame: 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.

    The primary outcome measure will be the comparison of survival rates between the treatment and control groups. A logistic regression analysis will be employed to evaluate the effect of Esmolol on survival rates and clinical outcomes, adjusting for potential confounders. Additionally, Kaplan-Meier survival curves will be generated for each group, and a Log-rank test will be used to compare the differences in survival rates over the study period.

  2. Improvement in Organ Function and Inflammatory Markers

    Time frame: 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.

    As a secondary outcome, the study will assess the effect of Esmolol on organ function and systemic inflammation. This will be evaluated using a composite of changes in organ function scores (such as SOFA - Sequential Organ Failure Assessment score) and levels of inflammatory markers (such as C-reactive protein and IL-6). The analysis will determine if Esmolol correlates with an improvement in these clinical parameters, suggesting a protective or restorative effect on organ function.

Secondary outcomes

  1. Length of Intensive Care Unit (ICU) Stay

    Time frame: From the date of ICU admission until the date of ICU discharge, assessed up to 90 days.

    The duration of ICU stay will be measured to determine if Esmolol administration correlates with a shorter ICU admission period. This measure can reflect the overall impact of the drug on the severity and progression of sepsis, potentially indicating more rapid patient stabilization and recovery.

  2. Reduction in Inflammatory Markers

    Time frame: Baseline and then daily measurements in ICU up to 28 days.

    The study will evaluate the effect of Esmolol on systemic inflammation by measuring changes in inflammatory markers such as C-reactive protein (CRP) and interleukin-6 (IL-6) levels. A decrease in these markers could indicate a beneficial anti-inflammatory effect of the drug.

Sponsors and collaborators

Lead sponsor

Lin Chen

Other

Registry information

Official study title

Investigating the Immunomodulatory Effects of Esmolol in Sepsis Management and Its Impact on Patient Outcomes

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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