The Effect of Esmolol on Patients With Sepsis

Sepsis Clinical Trial

Official title:

The Effect of Esmolol on Patients With Sepsis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04537767
• Other study ID #: ES-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• sepsis patients

• HR>100bpm 6h after admission

• with CVC and ScvO2>65%

Exclusion Criteria:

• age <18 years,

• used ß-blocker before,

• cardiac dysrhythmias,

• need for an inotropic agent,

• valvular heart disease,

• hemoglobin>6g/L

• pregnancy.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• Esmolol
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.
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	REE	Resting energy expenditure	Day 7 after enrollment
Secondary	28-day mortality rate	28-day mortality rate	Day 28 after enrollment
Secondary	HR control rate	target heart rate control rate	24 hours after enrollment
Secondary	Vasoactive drug administration dose	Vasoactive drug administration dose	Day 1/3/7 after enrollment
Secondary	Concentration of Lac	Concentration of lactic acid	Day 1/3/7 after enrollment
Secondary	O2ER	oxygen extraction rate	Day 1/3/7 after enrollment