Clinical trial

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

Name

SichuanPPHLC02

Description

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

Trial arms

Trial start

2021-01-01

Estimated PCD

2023-12-31

Trial end

2023-12-31

Status

Completed

Phase

Early phase I

Treatment

esmolol

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.

Arms:

standard care plus esmolol

Size

150

Primary endpoint

Impact of Esmolol on Survival Rates

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.

Improvement in Organ Function and Inflammatory Markers

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.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "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.", 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}

Updated at

2024-05-29

1 organization

1 product

7 indications

Organization

Lin Chen

Product

esmolol

Indication

Sepsis

Indication