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

Not Applicable

• Conditions: Cardiogenic Shock; Heart Failure
• Interventions: Procedure: adjust dobutamine according to the attending physician; Procedure: adjust dobutamine according to the ejection volume index

• Registration Number: NCT03727282
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Last Update Submitted: 2018-10-30
• Study First Posted: 2018-11-01
• Last Update Posted: 2018-11-01
• Study Start: 2019-01-02
• Primary Completion: 2020-01-02
• Study Completion: 2021-01-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal strategy	adjust dobutamine according to the attending physician	Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician
ejection volume index	adjust dobutamine according to the ejection volume index	Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index

Primary Outcome Measures

Name	Time	Method
cardiac output	24 hours	echocardiography echocardiography
systolic and diastolic blood pressure	24 hours	physical evaluation
bicarbonate levels	24 hours	serum analysis
systolic volume	24 hours	echocardiography
central venous oxygen saturation levels	24 hours	serum analysis
heart rate	24 hours	physical evaluation
base excess levels	24 hours	serum analysis
arterial lactate levels	24 hours	serum analysis
creatinine levels	24 hours	serum analysis
urinary output	24 hours	urine analysis
BNP levels	24 hours	plasma analysis
urea levels	24 hours	serum analysis
troponin levels	24 hours	serum analysis

Secondary Outcome Measures

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