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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03727282
• Other study ID #: VTI-TAPSE
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: January 2, 2021

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre Soeiro, MD
• Phone: 1126615299
• Email: alexandre.soeiro[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2, 2021
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Heart Failure
• Shock
• Shock, Cardiogenic

Intervention

Procedure:
• adjust dobutamine according to the ejection volume index
adjust dobutamine dose
• adjust dobutamine according to the attending physician
adjust dobutamine dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	base excess levels	serum analysis	24 hours
Primary	bicarbonate levels	serum analysis	24 hours
Primary	systolic and diastolic blood pressure	physical evaluation	24 hours
Primary	cardiac output	echocardiography echocardiography	24 hours
Primary	systolic volume	echocardiography	24 hours
Primary	urinary output	urine analysis	24 hours
Primary	arterial lactate levels	serum analysis	24 hours
Primary	central venous oxygen saturation levels	serum analysis	24 hours
Primary	BNP levels	plasma analysis	24 hours
Primary	troponin levels	serum analysis	24 hours
Primary	heart rate	physical evaluation	24 hours
Primary	creatinine levels	serum analysis	24 hours
Primary	urea levels	serum analysis	24 hours
Secondary	occurrence of sustained ventricular arrhythmia	electrocardiography	24 hours
Secondary	need for orotracheal intubation		24 hours
Secondary	need for vasopressor or other inotropic association	hipotension	24 hours
Secondary	need for mechanical circulatory assistance		24 hours
Secondary	lowering of consciousness level	glasgow < 14	24 hours
Secondary	cardiorespiratory arrest		24 hours
Secondary	worsening of renal function	increase 0.5 mg / dl in relation to admission creatinine	24 hours
Secondary	death		24 hours
Secondary	failure of dobutamine weaning up		7 days
Secondary	hospitalization time		30 days