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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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ClinicalTrials.gov Identifier: NCT03727282
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Heart Failure Procedure: adjust dobutamine according to the ejection volume index Procedure: adjust dobutamine according to the attending physician Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : January 2, 2020
Estimated Study Completion Date : January 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Shock

Arm Intervention/treatment
Liberal strategy
Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician
Procedure: adjust dobutamine according to the attending physician
adjust dobutamine dose

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




Primary Outcome Measures :
  1. base excess levels [ Time Frame: 24 hours ]
    serum analysis

  2. bicarbonate levels [ Time Frame: 24 hours ]
    serum analysis

  3. systolic and diastolic blood pressure [ Time Frame: 24 hours ]
    physical evaluation

  4. cardiac output [ Time Frame: 24 hours ]
    echocardiography echocardiography

  5. systolic volume [ Time Frame: 24 hours ]
    echocardiography

  6. urinary output [ Time Frame: 24 hours ]
    urine analysis

  7. arterial lactate levels [ Time Frame: 24 hours ]
    serum analysis

  8. central venous oxygen saturation levels [ Time Frame: 24 hours ]
    serum analysis

  9. BNP levels [ Time Frame: 24 hours ]
    plasma analysis

  10. troponin levels [ Time Frame: 24 hours ]
    serum analysis

  11. heart rate [ Time Frame: 24 hours ]
    physical evaluation

  12. creatinine levels [ Time Frame: 24 hours ]
    serum analysis

  13. urea levels [ Time Frame: 24 hours ]
    serum analysis


Secondary Outcome Measures :
  1. occurrence of sustained ventricular arrhythmia [ Time Frame: 24 hours ]
    electrocardiography

  2. need for orotracheal intubation [ Time Frame: 24 hours ]
  3. need for vasopressor or other inotropic association [ Time Frame: 24 hours ]
    hipotension

  4. need for mechanical circulatory assistance [ Time Frame: 24 hours ]
  5. lowering of consciousness level [ Time Frame: 24 hours ]
    glasgow < 14

  6. cardiorespiratory arrest [ Time Frame: 24 hours ]
  7. worsening of renal function [ Time Frame: 24 hours ]
    increase 0.5 mg / dl in relation to admission creatinine

  8. death [ Time Frame: 24 hours ]
  9. failure of dobutamine weaning up [ Time Frame: 7 days ]
  10. hospitalization time [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727282


Contacts
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Contact: Alexandre Soeiro, MD 1126615299 alexandre.soeiro@bol.com.br

Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Mucio Tavares, MD Unidade Clínica de Emergência

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03727282     History of Changes
Other Study ID Numbers: VTI-TAPSE
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Shock, Cardiogenic
Shock
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents