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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiogenic Shock
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 30
- Primary Endpoint
- cardiac output
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
- •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 / m
- •Use of oral anticoagulant.
- •Acute coronary syndrome.
- •Indication of use of another inotropic other than dobutamine.
- •Orotracheal intubation.
- •Presence of significant pericardial effusion.
Outcomes
Primary Outcomes
cardiac output
Time Frame: 24 hours
echocardiography echocardiography
systolic and diastolic blood pressure
Time Frame: 24 hours
physical evaluation
bicarbonate levels
Time Frame: 24 hours
serum analysis
systolic volume
Time Frame: 24 hours
echocardiography
central venous oxygen saturation levels
Time Frame: 24 hours
serum analysis
heart rate
Time Frame: 24 hours
physical evaluation
base excess levels
Time Frame: 24 hours
serum analysis
arterial lactate levels
Time Frame: 24 hours
serum analysis
creatinine levels
Time Frame: 24 hours
serum analysis
urinary output
Time Frame: 24 hours
urine analysis
urea levels
Time Frame: 24 hours
serum analysis
BNP levels
Time Frame: 24 hours
plasma analysis
troponin levels
Time Frame: 24 hours
serum analysis
Secondary Outcomes
- worsening of renal function(24 hours)
- occurrence of sustained ventricular arrhythmia(24 hours)
- lowering of consciousness level(24 hours)
- 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)
- need for mechanical circulatory assistance(24 hours)
- death(24 hours)
- hospitalization time(30 days)