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Left Ventricular Volume Index in the Adjustment of Initial Dose of Dobutamine in Heart Failure and Cardiogenic Shock

Primary Purpose

Cardiogenic Shock, Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
adjust dobutamine according to the ejection volume index
adjust dobutamine according to the attending physician
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock

Eligibility Criteria

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

Inclusion Criteria:

  • LVEF ≤ 40% documented on echocardiography
  • BNP> 500 pg / mL

  • Need for initiation of dobutamine and signs or symptoms of low cardiac output at admission defined by the presence of 2 or more of the following:

    • SBP ≤ 95 mmHg
    • FC> 100 bpm
    • Peripheral vasoconstriction,
    • Cold extremities,
    • Reference of decrease of urine output,
    • Nausea, vomiting and food intolerance,
    • Presence of organic dysfunction

Exclusion Criteria:

  • Pregnancy.
  • COPD
  • Hepatical cirrhosis
  • Atrioventricular block of 2nd or 3rd degree. and. SBP <80 mmHg or need for vasopressor.
  • Use of definitive pacemaker.
  • Body mass index greater than 40 kg / m2.
  • Use of oral anticoagulant.
  • Acute coronary syndrome.
  • Indication of use of another inotropic other than dobutamine.
  • Orotracheal intubation.
  • Presence of significant pericardial effusion.
  • Obstruction of left ventricular outflow tract.
  • Serum creatinine> 5.0 mg / dL or hemodialysis.
  • Presence of 2 or more clinical / laboratory / radiological criteria of infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Liberal strategy

    ejection volume index

    Arm Description

    Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician

    Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index

    Outcomes

    Primary Outcome Measures

    base excess levels
    serum analysis
    bicarbonate levels
    serum analysis
    systolic and diastolic blood pressure
    physical evaluation
    cardiac output
    echocardiography echocardiography
    systolic volume
    echocardiography
    urinary output
    urine analysis
    arterial lactate levels
    serum analysis
    central venous oxygen saturation levels
    serum analysis
    BNP levels
    plasma analysis
    troponin levels
    serum analysis
    heart rate
    physical evaluation
    creatinine levels
    serum analysis
    urea levels
    serum analysis

    Secondary Outcome Measures

    occurrence of sustained ventricular arrhythmia
    electrocardiography
    need for orotracheal intubation
    need for vasopressor or other inotropic association
    hipotension
    need for mechanical circulatory assistance
    lowering of consciousness level
    glasgow < 14
    cardiorespiratory arrest
    worsening of renal function
    increase 0.5 mg / dl in relation to admission creatinine
    death
    failure of dobutamine weaning up
    hospitalization time

    Full Information

    First Posted
    October 30, 2018
    Last Updated
    October 30, 2018
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03727282
    Brief Title
    Left Ventricular Volume Index in the Adjustment of Initial Dose of Dobutamine in Heart Failure and Cardiogenic Shock
    Official Title
    Use of Transtoracic Ecocargiogram With Calculation of Left Ventricular Volume Index in the Initial Adjustment of Initial Dose of Dobutamine in Patients With Heart Failure and Cardiogenic Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2, 2019 (Anticipated)
    Primary Completion Date
    January 2, 2020 (Anticipated)
    Study Completion Date
    January 2, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Sao Paulo General Hospital

    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
    Recent studies have suggested that the use of left ventricular ejection volume index calculation may aid in the hemodynamic management of critically ill patients. However, a prospective and randomized comparison in patients with heart failure for inotropic dose adjustment has not been described. The objective of this study was to evaluate the efficacy and safety of ejection volume index versus liberal strategy in adjusting dobutamine dose in patients with heart failure and low cardiac output. Methodology: A unicentric, randomized and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, dobutamine dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of ejection volume index is not inferior to the liberal strategy in the initial adjustment of the dose of dobutamine in patients with heart failure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiogenic Shock, Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Liberal strategy
    Arm Type
    Other
    Arm Description
    Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician
    Arm Title
    ejection volume index
    Arm Type
    Experimental
    Arm Description
    Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index
    Intervention Type
    Procedure
    Intervention Name(s)
    adjust dobutamine according to the ejection volume index
    Intervention Description
    adjust dobutamine dose
    Intervention Type
    Procedure
    Intervention Name(s)
    adjust dobutamine according to the attending physician
    Intervention Description
    adjust dobutamine dose
    Primary Outcome Measure Information:
    Title
    base excess levels
    Description
    serum analysis
    Time Frame
    24 hours
    Title
    bicarbonate levels
    Description
    serum analysis
    Time Frame
    24 hours
    Title
    systolic and diastolic blood pressure
    Description
    physical evaluation
    Time Frame
    24 hours
    Title
    cardiac output
    Description
    echocardiography echocardiography
    Time Frame
    24 hours
    Title
    systolic volume
    Description
    echocardiography
    Time Frame
    24 hours
    Title
    urinary output
    Description
    urine analysis
    Time Frame
    24 hours
    Title
    arterial lactate levels
    Description
    serum analysis
    Time Frame
    24 hours
    Title
    central venous oxygen saturation levels
    Description
    serum analysis
    Time Frame
    24 hours
    Title
    BNP levels
    Description
    plasma analysis
    Time Frame
    24 hours
    Title
    troponin levels
    Description
    serum analysis
    Time Frame
    24 hours
    Title
    heart rate
    Description
    physical evaluation
    Time Frame
    24 hours
    Title
    creatinine levels
    Description
    serum analysis
    Time Frame
    24 hours
    Title
    urea levels
    Description
    serum analysis
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    occurrence of sustained ventricular arrhythmia
    Description
    electrocardiography
    Time Frame
    24 hours
    Title
    need for orotracheal intubation
    Time Frame
    24 hours
    Title
    need for vasopressor or other inotropic association
    Description
    hipotension
    Time Frame
    24 hours
    Title
    need for mechanical circulatory assistance
    Time Frame
    24 hours
    Title
    lowering of consciousness level
    Description
    glasgow < 14
    Time Frame
    24 hours
    Title
    cardiorespiratory arrest
    Time Frame
    24 hours
    Title
    worsening of renal function
    Description
    increase 0.5 mg / dl in relation to admission creatinine
    Time Frame
    24 hours
    Title
    death
    Time Frame
    24 hours
    Title
    failure of dobutamine weaning up
    Time Frame
    7 days
    Title
    hospitalization time
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: LVEF ≤ 40% documented on echocardiography BNP> 500 pg / mL Need for initiation of dobutamine and signs or symptoms of low cardiac output at admission defined by the presence of 2 or more of the following: SBP ≤ 95 mmHg FC> 100 bpm Peripheral vasoconstriction, Cold extremities, Reference of decrease of urine output, Nausea, vomiting and food intolerance, Presence of organic dysfunction Exclusion Criteria: Pregnancy. COPD Hepatical cirrhosis Atrioventricular block of 2nd or 3rd degree. and. SBP <80 mmHg or need for vasopressor. Use of definitive pacemaker. Body mass index greater than 40 kg / m2. Use of oral anticoagulant. Acute coronary syndrome. Indication of use of another inotropic other than dobutamine. Orotracheal intubation. Presence of significant pericardial effusion. Obstruction of left ventricular outflow tract. Serum creatinine> 5.0 mg / dL or hemodialysis. Presence of 2 or more clinical / laboratory / radiological criteria of infection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandre Soeiro, MD
    Phone
    1126615299
    Email
    alexandre.soeiro@bol.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mucio Tavares, MD
    Organizational Affiliation
    Unidade Clínica de Emergência
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Left Ventricular Volume Index in the Adjustment of Initial Dose of Dobutamine in Heart Failure and Cardiogenic Shock

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