Investigating the Immunomodulatory Effects of Esmolol in Sepsis Management and Its Impact on Patient Outcomes
Phase: PHASE2
Conditions: Sepsis, Lymphocyte Disorder T, Immunologic Paralysis, Catecholamine; Overproduction, Beta-Blocker, Cytokine Storm, Sympathetic Nervous System Diseases
Sponsor: Lin Chen

Official Title: Investigating the Immunomodulatory Effects of Esmolol 
in Sepsis Management and Its Impact on Patient Outcomes 
 
NCT Number: Pending 
Study Duration: January 2020 to December 2021. 
Funding Source:  
Sichuan Provincial Healthcare Commission - Popularization Application Project 
(21PJ081); and the Sichuan Cadre Healthcare Scientific Research Project (General 
Subject Program) (Sichuan Cadre Research 2021-207). 
Principal Investigator: Dr. Lin Chen 
Affiliation: Sichuan Provincial People's Hospital 
Address: 32# W. Sec 2, 1st Ring Rd., Chengdu, Sichuan, China 
 
Contact Information: 
Email: chenlinhx@med.uestc.edu.cn 
Phone: +86 18111585286 
 
 
 
 
________________________________________ 
Document Date: March 2，2024 
 
 
 
 
 

 
Study Protocol 
 
Title: Esmolol in Sepsis Management: Evaluating Immunomodulatory Effects and Impact on 
Patient Outcomes 
Objective: Evaluate the effectiveness of esmolol, a selective β1-adrenergic receptor blocker, in 
modulating immune responses and improving patient outcomes in sepsis. 
Background: Sepsis remains a significant challenge in intensive care with high mortality rates and 
complex pathophysiology involving the immune system and sympathetic nervous system (SNS) 
interactions. This study investigates the efficacy of esmolol in modulating immune responses and 
improving patient outcomes in sepsis. 
Methodology: 
• 
Study Design: Single-center prospective controlled study comparing patient groups treated 
with either standard care or standard care plus esmolol based on clinical suitability and heart 
rate levels. 
• 
Participants: 105 patients diagnosed with sepsis or septic shock, admitted to the MICU/RICU 
of Sichuan Provincial People's Hospital from January 2021 to December 2022, with informed 
consent obtained. 
• 
Procedures: 
• 
Random assignment of patients to treatment groups. 
• 
Continuous monitoring and adjustment of esmolol dosage to maintain target heart rate. 
• 
Collection of data on inflammatory markers, immune function, hemodynamics, and 
clinical outcomes. 
• 
Ethics Approval: Granted by the Ethics Committee of Sichuan Provincial People's Hospital. 
Statistical Analysis Plan 
• 
Data Analysis Strategy: 
1. Descriptive Statistics: Summarize participant characteristics using means ± standard 
deviations for continuous variables and frequencies for categorical variables. 
2. Effectiveness Evaluation: Perform logistic regression to evaluate the impact of esmolol 
on survival rates and clinical outcomes. Kaplan-Meier survival analysis with Log-rank 
test for comparing survival rates between treatment groups. 
3. Comparison Between Groups: Use independent samples t-tests or Mann-Whitney U 
tests for continuous variables and chi-square tests for categorical variables to compare 
the esmolol and control groups across different measures. 
4. Correlation Analysis: Assess the relationship between baseline immune function 
markers and treatment response using Pearson’s or Spearman’s correlation coefficients, 
depending on data distribution. 
Software: Statistical analysis will be conducted using SPSS version 25.0 or a similar statistical package. 
Ethical Considerations: Data will be anonymized to protect patient confidentiality, with all procedures 
carried out in accordance with the Declaration of Helsinki.