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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Cardiogenic Shock
• Intervention / Treatment: Procedure: adjust dobutamine according to the attending physician; Procedure: adjust dobutamine according to the ejection volume index

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Soeiro, MD; Phone Number: 1126615299; Email: alexandre.soeiro@bol.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of sustained ventricular arrhythmia	electrocardiography	24 hours
need for orotracheal intubation		24 hours
need for vasopressor or other inotropic association	hipotension	24 hours
need for mechanical circulatory assistance		24 hours
lowering of consciousness level	glasgow < 14	24 hours
cardiorespiratory arrest		24 hours
worsening of renal function	increase 0.5 mg / dl in relation to admission creatinine	24 hours
death		24 hours
failure of dobutamine weaning up		7 days
hospitalization time		30 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 2, 2019
• Primary Completion (Anticipated): January 2, 2020
• Study Completion (Anticipated): January 2, 2021

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Heart Failure; Shock; Shock, Cardiogenic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: VTI-TAPSE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No