Investigating the Immunomodulatory Effects of Esmolol in Sepsis Management and Its Impact on Patient Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Impact of Esmolol on Survival Rates
研究概览
简要总结
Evaluate the effectiveness of esmolol, a selective β1-adrenergic receptor blocker, in modulating immune responses and improving patient outcomes in sepsis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This study employs a single-blind design where the participants are blinded to their treatment assignments. In this setup, the patients do not know whether they are receiving the intervention (Esmolol) or are in the control group receiving only standard sepsis care. This blinding is essential to mitigate placebo effects and bias in patient-reported outcomes. However, the care providers, as well as the investigators and outcomes assessors, are aware of the treatment assignments. This knowledge allows them to manage the care more effectively while maintaining a robust observational stance on the impact of the interventions. The single-blind design is chosen to ensure the integrity of the data collected, particularly in measuring clinical outcomes and patient responses, without influencing the patients' perceptions or expectations about the treatment they are receiving.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 90 years.
- •Diagnosed with sepsis or septic shock according to the diagnostic criteria in Suivival Sepsis of
- •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.
排除标准
- •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.
研究组 & 干预措施
standard care plus esmolol
Patients in this group were administered Esmolol, a beta-1 selective adrenergic blocker, alongside the standard sepsis care protocols. The dosage of Esmolol was adjusted to maintain heart rate within predefined targets. Additionally, daily electrocardiogram (ECG) monitoring was conducted to assess changes in the QT interval, a critical measure given the potential cardiac effects of beta-blockers. This group aimed to explore not only the immunomodulatory effects of Esmolol but also its safety profile in terms of cardiac function in septic patients.
干预措施: esmolol (Drug)
结局指标
主要结局
Impact of Esmolol on Survival Rates
时间窗: 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.
Improvement in Organ Function and Inflammatory Markers
时间窗: 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.
次要结局
- Length of Intensive Care Unit (ICU) Stay(From the date of ICU admission until the date of ICU discharge, assessed up to 90 days.)
- Reduction in Inflammatory Markers(Baseline and then daily measurements in ICU up to 28 days.)
研究者
Lin Chen
Professor
Sichuan Provincial People's Hospital