The Effect of Esmolol on Patients With Sepsis

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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