The Effect of Esmolol on Patients With Sepsis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04537767

Enrollment

120

Registered

2020-09-03

Start date

2020-10-01

Completion date

2023-09-30

Last updated

2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, septic shock, esmolol

Brief summary

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

Detailed 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.

Interventions

DRUGEsmolol

The protocol required a titrated esmolol infusion commenced at 25 mg/ h, with an upper dose limit of 2000 mg/h, to maintain the HR between 75 and 90 bpm in ES group. The control group were treated with placebo.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
REE	Day 7 after enrollment	Resting energy expenditure

Secondary

Measure	Time frame	Description
28-day mortality rate	Day 28 after enrollment	28-day mortality rate
HR control rate	24 hours after enrollment	target heart rate control rate
Vasoactive drug administration dose	Day 1/3/7 after enrollment	Vasoactive drug administration dose
Concentration of Lac	Day 1/3/7 after enrollment	Concentration of lactic acid
O2ER	Day 1/3/7 after enrollment	oxygen extraction rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026