CClinicalTrials.gg
Status unknownNCT04537767Updated Sep 3, 2020

The Effect of Esmolol on Patients With Sepsis

An interventional study of Esmolol and Placebo in Sepsis, sponsored by Shanghai Zhongshan Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Sepsis

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Keywords

  • sepsis
  • septic shock
  • esmolol
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 120 is above the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age \<18 years,
  • used β-blocker before,
  • cardiac dysrhythmias,
  • need for an inotropic agent,
  • valvular heart disease,
  • hemoglobin>6g/L
  • pregnancy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    ES group

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

    Drug: Esmolol

  • Placebo comparator
    control group

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

    Drug: Placebo

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

06

What researchers measure

Primary outcomes

  1. REE

    Resting energy expenditure

    Time frame: Day 7 after enrollment

Secondary outcomes

  1. 28-day mortality rate

    28-day mortality rate

    Time frame: Day 28 after enrollment

  2. HR control rate

    target heart rate control rate

    Time frame: 24 hours after enrollment

  3. Vasoactive drug administration dose

    Vasoactive drug administration dose

    Time frame: Day 1/3/7 after enrollment

  4. Concentration of Lac

    Concentration of lactic acid

    Time frame: Day 1/3/7 after enrollment

  5. O2ER

    oxygen extraction rate

    Time frame: Day 1/3/7 after enrollment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04537767
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Sep 3, 2020
Start date
Oct 1, 2020 (estimated)
Primary completion
Mar 31, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Sep 3, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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