Clinical trial NCT06390748: Esmolol in Sepsis Management:Evaluating Immunomodulatory Effects and Impact on Patient Outcomes
Official title: Investigating the Immunomodulatory Effects of Esmolol in Sepsis Management and Its Impact on Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sepsis
Lymphocyte Disorder T
Immunologic Paralysis
Catecholamine; Overproduction
Beta-Blocker
Cytokine Storm
Sympathetic Nervous System Diseases
Keywords: Esmolol
Sepsis
Immune modulation
T-cell function
Inflammatory markers
Sympathetic Nervous System
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a parallel assignment model to investigate the effects of Esmolol on patients with sepsis. Participants are randomly assigned to one of two groups. The first group, the intervention group, receives Esmolol in addition to the standard sepsis care, which includes antibiotics, fluid resuscitation, and other supportive therapies. Esmolol dosing is adjusted to achieve and maintain specific heart rate targets, and cardiac monitoring through daily electrocardiograms is implemented to track QT interval changes. The second group, the control group, receives only the standard sepsis care without any additional interventions.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Deceased within three days following ICU admission.
2. Pregnant or lactating individuals.
3. Underwent surgical procedures within the last two weeks.
4. Severe cardiac failure exceeding NYHA Class III.
5. Usage of long-term oral β-blockers or any form of extracorporeal circulation within the last two weeks.
6. Presenting with sinus bradycardia or atrioventricular block.
7. Received high doses of corticosteroids in the past three months.
8. 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.

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
measure: Length of Intensive Care Unit (ICU) Stay
timeFrame: From the date of ICU admission until the date of ICU discharge, assessed up to 90 days.
measure: Reduction in Inflammatory Markers
timeFrame: Baseline and then daily measurements in ICU up to 28 days.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Lin Chen, doctoral
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedicino D, Volpe M. beta1-Adrenergic receptor stimulation modulates immune response in cancer: a role for beta-blockers in antineoplastic treatment? Eur Heart J. 2024 Mar 14;45(11):870-871. doi: 10.1093/eurheartj/ehae008. No abstract available.