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

Lin Chen

Status and phase: Completed; Phase 2

Conditions: Beta-Blocker; Lymphocyte Disorder T; Sympathetic Nervous System Diseases; Immunologic Paralysis; Cytokine Storm; Catecholamine; Overproduction; Sepsis

Treatments: Drug: esmolol

Study type: Interventional

Funder types: Other

Identifiers

NCT06390748

SichuanPPHLC02

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

standard care plus esmolol

Experimental group

Description:

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.

Treatment:

Drug: esmolol

standard care

No Intervention group

Description:

Patients in this cohort received the standard of care for sepsis without any additional intervention. This treatment included antibiotics, fluids, and other supportive therapies as dictated by current clinical guidelines for sepsis management.