NCT04537767

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable sepsis

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

2.5 years

First QC Date

June 14, 2020

Last Update Submit

September 2, 2020

Conditions

Sepsis

Keywords

sepsisseptic shockesmolol

Outcome Measures

Primary Outcomes (1)

  • REE

    Resting energy expenditure

    Day 7 after enrollment

Secondary Outcomes (5)

  • 28-day mortality rate

    Day 28 after enrollment

  • HR control rate

    24 hours after enrollment

  • Vasoactive drug administration dose

    Day 1/3/7 after enrollment

  • Concentration of Lac

    Day 1/3/7 after enrollment

  • O2ER

    Day 1/3/7 after enrollment

Study Arms (2)

ES group

EXPERIMENTAL

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

Drug: Esmolol

control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EsmololDRUG

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.

ES group
PlaceboDRUG

Placebo

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

esmolol

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2020

First Posted

September 3, 2020

Study Start

October 1, 2020

Primary Completion

March 31, 2023

Study Completion

September 30, 2023

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share