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The Effect of Esmolol on Patients With Sepsis

Primary Purpose

Sepsis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esmolol
Placebo
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, septic shock, esmolol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ES group

    control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    REE
    Resting energy expenditure

    Secondary Outcome Measures

    28-day mortality rate
    28-day mortality rate
    HR control rate
    target heart rate control rate
    Vasoactive drug administration dose
    Vasoactive drug administration dose
    Concentration of Lac
    Concentration of lactic acid
    O2ER
    oxygen extraction rate

    Full Information

    First Posted
    June 14, 2020
    Last Updated
    September 2, 2020
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04537767
    Brief Title
    The Effect of Esmolol on Patients With Sepsis
    Official Title
    The Effect of Esmolol on Patients With Sepsis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    March 31, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis
    Keywords
    sepsis, septic shock, esmolol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ES group
    Arm Type
    Experimental
    Arm Description
    Patients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients randomly assigned to the control group were treated with placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Esmolol
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    REE
    Description
    Resting energy expenditure
    Time Frame
    Day 7 after enrollment
    Secondary Outcome Measure Information:
    Title
    28-day mortality rate
    Description
    28-day mortality rate
    Time Frame
    Day 28 after enrollment
    Title
    HR control rate
    Description
    target heart rate control rate
    Time Frame
    24 hours after enrollment
    Title
    Vasoactive drug administration dose
    Description
    Vasoactive drug administration dose
    Time Frame
    Day 1/3/7 after enrollment
    Title
    Concentration of Lac
    Description
    Concentration of lactic acid
    Time Frame
    Day 1/3/7 after enrollment
    Title
    O2ER
    Description
    oxygen extraction rate
    Time Frame
    Day 1/3/7 after enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Esmolol on Patients With Sepsis

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