NCT03727282

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.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

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

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2021

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 30, 2018

Last Update Submit

October 30, 2018

Conditions

Cardiogenic ShockHeart Failure

Outcome Measures

Primary Outcomes (13)

  • base excess levels

    serum analysis

    24 hours

  • bicarbonate levels

    serum analysis

    24 hours

  • systolic and diastolic blood pressure

    physical evaluation

    24 hours

  • cardiac output

    echocardiography echocardiography

    24 hours

  • systolic volume

    echocardiography

    24 hours

  • urinary output

    urine analysis

    24 hours

  • arterial lactate levels

    serum analysis

    24 hours

  • central venous oxygen saturation levels

    serum analysis

    24 hours

  • BNP levels

    plasma analysis

    24 hours

  • troponin levels

    serum analysis

    24 hours

  • heart rate

    physical evaluation

    24 hours

  • creatinine levels

    serum analysis

    24 hours

  • urea levels

    serum analysis

    24 hours

Secondary Outcomes (10)

  • occurrence of sustained ventricular arrhythmia

    24 hours

  • need for orotracheal intubation

    24 hours

  • need for vasopressor or other inotropic association

    24 hours

  • need for mechanical circulatory assistance

    24 hours

  • lowering of consciousness level

    24 hours

  • +5 more secondary outcomes

Study Arms (2)

Liberal strategy

OTHER

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

Procedure: adjust dobutamine according to the attending physician

ejection volume index

EXPERIMENTAL

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

Interventions

adjust dobutamine according to the ejection volume indexPROCEDURE

adjust dobutamine dose

ejection volume index
adjust dobutamine according to the attending physicianPROCEDURE

adjust dobutamine dose

Liberal strategy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock, CardiogenicHeart Failure

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Mucio Tavares, MD

    Unidade Clínica de Emergência

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Soeiro, MD

CONTACT

1126615299alexandre.soeiro@bol.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 1, 2018

Study Start

January 2, 2019

Primary Completion

January 2, 2020

Study Completion

January 2, 2021

Last Updated

November 1, 2018

Record last verified: 2018-10