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Effects of Heart Control at Different Stages in Patients of Septic Shock With Tachycardia

Primary Purpose

Septic Shock, Tachycardia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esmolol
Sponsored by
Chinese Medical Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic Shock, Tachycardia, β receptor blockers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

" ≥ 18 years old; " New septic shock within 24 hours, meeting the diagnostic criteria in 2012; " Septic shock lasts for more than 6 hours, and after fluid optimization using dynamic parameters, vasoactive drugs are still needed to maintain blood pressure; " the heart rate is greater than 100 beats / min for ≥ 1 hour,not caused by agitation, fever, and other factors; " informed consents are signed.

Exclusion Criteria:

" Shock caused by sepsis; " Septic cardiomyopathy or decreased myocardial contractility, requiring the use of positive inotropic drugs or significant cardiac insufficiency, such as CI ≤ 2.2l/min m2, PAWP>18mmHg, EF<40%; " Severe bronchial asthma or COPD; " Pregnant or lactating women; " Sinus bradycardia, degree II and degree III heart block; " β-receptor blockers were used before enrollment or have the history of sinus tachycardia; " Severe valvular heart disease; " Allergic to esmolol; " Tachycardia due to elevated body temperature, agitation, insufficient capacity and other reasons; " Have participated in other clinical studies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    Esmolol is used 6 to 24 hours after onset of septic shock in patients with fluid optimization to control heart beats between 70-100bpm.

    Esmolol is used 24 hours after onset of septic shock in patients to control heart beats between 70-100bpm.

    patients received conventional therapy in accordance with septic shock guidelines 2021

    Outcomes

    Primary Outcome Measures

    the proportion of patients with heart rate of 70-100 bpm
    the proportion of patients with heart rate of 70-100 bpm
    the proportion of patients with heart rate of 70-100 bpm
    the proportion of patients with heart rate of 70-100 bpm
    the proportion of patients with heart rate of 70-100 bpm
    the proportion of patients with heart rate of 70-100 bpm
    the proportion of patients with heart rate of 70-100 bpm
    the proportion of patients with heart rate of 70-100 bpm

    Secondary Outcome Measures

    cardiac index
    PiCCO monitoring parameters
    cardiac index
    PiCCO monitoring parameters
    cardiac index
    PiCCO monitoring parameters
    cardiac index
    PiCCO monitoring parameters
    ejection fraction
    cardiac measurement by cardiac ultrasound
    ejection fraction
    cardiac measurement by cardiac ultrasound
    ejection fraction
    cardiac measurement by cardiac ultrasound
    ejection fraction
    cardiac measurement by cardiac ultrasound
    Arterial blood PH value
    Arterial blood PH value by arterial blood gas analysis
    Arterial blood PH value
    Arterial blood PH value by arterial blood gas analysis
    Arterial blood PH value
    Arterial blood PH value by arterial blood gas analysis
    Arterial blood PH value
    Arterial blood PH value by arterial blood gas analysis
    Arterial blood lactate
    Arterial blood lactate by arterial blood gas analysis
    Arterial blood lactate
    Arterial blood lactate by arterial blood gas analysis
    Arterial blood lactate
    Arterial blood lactate by arterial blood gas analysis
    Arterial blood lactate
    Arterial blood lactate by arterial blood gas analysis
    APACHEII scores
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    APACHEII scores
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    APACHEII scores
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    APACHEII scores
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    SOFA scores
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    SOFA scores
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    SOFA scores
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    SOFA scores
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    norepinephrine dose
    norepinephrine dose (ug/kg.min)
    norepinephrine dose
    norepinephrine dose (ug/kg.min)
    norepinephrine dose
    norepinephrine dose (ug/kg.min)
    norepinephrine dose
    norepinephrine dose (ug/kg.min)
    ICU- free days (by 28 days)
    days free of ICU
    28-day mortality
    28-day mortality
    days of mechanical ventilation
    days of mechanical ventilation
    the incidence of hypotension deteriorated
    the incidence of hypotension deteriorated
    the incidence of heart arrest
    the incidence of heart arrest

    Full Information

    First Posted
    April 28, 2022
    Last Updated
    May 19, 2022
    Sponsor
    Chinese Medical Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05389176
    Brief Title
    Effects of Heart Control at Different Stages in Patients of Septic Shock With Tachycardia
    Official Title
    Effects of Heart Control at Different Stages on Hemodynamics Parameters and Clinical Prognosis in Patients of Septic Shock With Tachycardia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chinese Medical Association

    4. Oversight

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

    5. Study Description

    Brief Summary
    A sigle-center, randomized controlled trial will be do to investigate the effects of esomol on heart rate, clinical parameters, mortality, and safety in septic shock patients with tachycardia at different stages, compared with patients who received conventional therapy.
    Detailed Description
    The incidence of septic shock complicated with tachycardia is high and the prognosis is poor. Enough attention should be paid to and appropriate treatment should be given. High heart rate and high cardiac output are beneficial compensatory reactions of sepsis and septic shock. However, excessive sympathetic activation and high heart rate also have adverse effects on the cardiovascular system. Sustained tachycardia is harmful to patients with sepsis and septic shock and needs to be controlled. At present, it is widely used in the treatment of cardiovascular diseases and β Receptor blockers have the functions of preventing and reversing sympathetic effects, anti arrhythmia, anti-inflammatory and balancing myocardial oxygen supply and demand. Therefore, they are recommended to control arrhythmias in patients with septic shock. The 2014 guidelines for sepsis / septic shock in China suggest that if cardiac output is not low and the heart rate is fast after adequate fluid resuscitation, short acting drugs(β Receptor blockers)can be considered. However, there are some differences in the current clinical research results, and it suggests that the timing of treatment may affect the hemodynamic results and clinical outcomes of patients. Therefore, this study intends to intervene with esmolol in patients with septic shock and tachycardia at different stages, and compare the hemodynamic parameters, clinical outcome, prognosis and adverse reactions with the conventional treatment group, in order to explore the appropriate time of esmolol in the treatment of patients with septic shock and tachycardia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock, Tachycardia
    Keywords
    Septic Shock, Tachycardia, β receptor blockers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Esmolol is used 6 to 24 hours after onset of septic shock in patients with fluid optimization to control heart beats between 70-100bpm.
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Esmolol is used 24 hours after onset of septic shock in patients to control heart beats between 70-100bpm.
    Arm Title
    Group C
    Arm Type
    No Intervention
    Arm Description
    patients received conventional therapy in accordance with septic shock guidelines 2021
    Intervention Type
    Drug
    Intervention Name(s)
    Esmolol
    Other Intervention Name(s)
    β-receptor blockers
    Intervention Description
    a continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min
    Primary Outcome Measure Information:
    Title
    the proportion of patients with heart rate of 70-100 bpm
    Description
    the proportion of patients with heart rate of 70-100 bpm
    Time Frame
    at 24-hour after randomization
    Title
    the proportion of patients with heart rate of 70-100 bpm
    Description
    the proportion of patients with heart rate of 70-100 bpm
    Time Frame
    at 48-hour after randomization
    Title
    the proportion of patients with heart rate of 70-100 bpm
    Description
    the proportion of patients with heart rate of 70-100 bpm
    Time Frame
    at 72-hour after randomization
    Title
    the proportion of patients with heart rate of 70-100 bpm
    Description
    the proportion of patients with heart rate of 70-100 bpm
    Time Frame
    at 96-hour after randomization
    Secondary Outcome Measure Information:
    Title
    cardiac index
    Description
    PiCCO monitoring parameters
    Time Frame
    at 24-hour after randomization
    Title
    cardiac index
    Description
    PiCCO monitoring parameters
    Time Frame
    at 48-hour after randomization
    Title
    cardiac index
    Description
    PiCCO monitoring parameters
    Time Frame
    at 72-hour after randomization
    Title
    cardiac index
    Description
    PiCCO monitoring parameters
    Time Frame
    at 96-hour after randomization
    Title
    ejection fraction
    Description
    cardiac measurement by cardiac ultrasound
    Time Frame
    at 24-hour after randomization
    Title
    ejection fraction
    Description
    cardiac measurement by cardiac ultrasound
    Time Frame
    at 48-hour after randomization
    Title
    ejection fraction
    Description
    cardiac measurement by cardiac ultrasound
    Time Frame
    at 72-hour after randomization
    Title
    ejection fraction
    Description
    cardiac measurement by cardiac ultrasound
    Time Frame
    at 96-hour after randomization
    Title
    Arterial blood PH value
    Description
    Arterial blood PH value by arterial blood gas analysis
    Time Frame
    at 24-hour after randomization
    Title
    Arterial blood PH value
    Description
    Arterial blood PH value by arterial blood gas analysis
    Time Frame
    at 48-hour after randomization
    Title
    Arterial blood PH value
    Description
    Arterial blood PH value by arterial blood gas analysis
    Time Frame
    at 72-hour after randomization
    Title
    Arterial blood PH value
    Description
    Arterial blood PH value by arterial blood gas analysis
    Time Frame
    at 96-hour after randomization
    Title
    Arterial blood lactate
    Description
    Arterial blood lactate by arterial blood gas analysis
    Time Frame
    at 24-hour after randomization
    Title
    Arterial blood lactate
    Description
    Arterial blood lactate by arterial blood gas analysis
    Time Frame
    at 48-hour after randomization
    Title
    Arterial blood lactate
    Description
    Arterial blood lactate by arterial blood gas analysis
    Time Frame
    at 72-hour after randomization
    Title
    Arterial blood lactate
    Description
    Arterial blood lactate by arterial blood gas analysis
    Time Frame
    at 96-hour after randomization
    Title
    APACHEII scores
    Description
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    Time Frame
    at 24-hour after randomization
    Title
    APACHEII scores
    Description
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    Time Frame
    at 48-hour after randomization
    Title
    APACHEII scores
    Description
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    Time Frame
    at 72-hour after randomization
    Title
    APACHEII scores
    Description
    the Acute Physiology and Chronic Health Evaluation II scores,value 0~60, the higher score means worse outcome.
    Time Frame
    at 96-hour after randomization
    Title
    SOFA scores
    Description
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    Time Frame
    at 24-hour after randomization
    Title
    SOFA scores
    Description
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    Time Frame
    at 48-hour after randomization
    Title
    SOFA scores
    Description
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    Time Frame
    at 72-hour after randomization
    Title
    SOFA scores
    Description
    sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.
    Time Frame
    at 96-hour after randomization
    Title
    norepinephrine dose
    Description
    norepinephrine dose (ug/kg.min)
    Time Frame
    at 24-hour after randomization
    Title
    norepinephrine dose
    Description
    norepinephrine dose (ug/kg.min)
    Time Frame
    at 48-hour after randomization
    Title
    norepinephrine dose
    Description
    norepinephrine dose (ug/kg.min)
    Time Frame
    at 72-hour after randomization
    Title
    norepinephrine dose
    Description
    norepinephrine dose (ug/kg.min)
    Time Frame
    at 96-hour after randomization
    Title
    ICU- free days (by 28 days)
    Description
    days free of ICU
    Time Frame
    from randomization until 28 days
    Title
    28-day mortality
    Description
    28-day mortality
    Time Frame
    from randomization until 28 days
    Title
    days of mechanical ventilation
    Description
    days of mechanical ventilation
    Time Frame
    from randomization until 28 days
    Title
    the incidence of hypotension deteriorated
    Description
    the incidence of hypotension deteriorated
    Time Frame
    by 96-hour after randomization
    Title
    the incidence of heart arrest
    Description
    the incidence of heart arrest
    Time Frame
    by 96-hour after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: " ≥ 18 years old; " New septic shock within 24 hours, meeting the diagnostic criteria in 2012; " Septic shock lasts for more than 6 hours, and after fluid optimization using dynamic parameters, vasoactive drugs are still needed to maintain blood pressure; " the heart rate is greater than 100 beats / min for ≥ 1 hour,not caused by agitation, fever, and other factors; " informed consents are signed. Exclusion Criteria: " Shock caused by sepsis; " Septic cardiomyopathy or decreased myocardial contractility, requiring the use of positive inotropic drugs or significant cardiac insufficiency, such as CI ≤ 2.2l/min m2, PAWP>18mmHg, EF<40%; " Severe bronchial asthma or COPD; " Pregnant or lactating women; " Sinus bradycardia, degree II and degree III heart block; " β-receptor blockers were used before enrollment or have the history of sinus tachycardia; " Severe valvular heart disease; " Allergic to esmolol; " Tachycardia due to elevated body temperature, agitation, insufficient capacity and other reasons; " Have participated in other clinical studies.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Wang, MD
    Phone
    +86-025-83106666-40400
    Email
    a_nengneng@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wenkui Yu, MD
    Organizational Affiliation
    The Affliated Drum Tower Hospital, Medical School of Nanjing University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Heart Control at Different Stages in Patients of Septic Shock With Tachycardia

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