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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Heart Failure; Cardiogenic Shock

Treatments: Procedure: adjust dobutamine according to the ejection volume index; Procedure: adjust dobutamine according to the attending physician

Study type: Interventional

Funder types: Other

Identifiers

NCT03727282

VTI-TAPSE

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Liberal strategy

Other group

Description:

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

Treatment:

Procedure: adjust dobutamine according to the attending physician

ejection volume index

Experimental group

Description:

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

Treatment:

Procedure: adjust dobutamine according to the ejection volume index