The Effect of Esmolol on Patients With Sepsis

Fudan University

Status: Not yet enrolling

Conditions: Sepsis

Treatments: Drug: Placebo; Drug: Esmolol

Study type: Interventional

Funder types: Other

Identifiers

NCT04537767

ES-01

Details and patient eligibility

About

The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Full description

Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• sepsis patients
• HR>100bpm 6h after admission
• with CVC and ScvO2>65%

Exclusion criteria

• age <18 years,
• used β-blocker before,
• cardiac dysrhythmias,
• need for an inotropic agent,
• valvular heart disease,
• hemoglobin>6g/L
• pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

ES group

Experimental group

Description:

Patients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range.

Treatment:

Drug: Esmolol

control group

Placebo Comparator group

Description:

Patients randomly assigned to the control group were treated with placebo.

Treatment:

Drug: Placebo