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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal strategy | Other | Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician |
|
| ejection volume index | Experimental | Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjust dobutamine according to the ejection volume index | Procedure | adjust dobutamine dose |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of sustained ventricular arrhythmia | electrocardiography | 24 hours |
| need for orotracheal intubation | 24 hours | |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Soeiro, MD | Contact | 1126615299 | alexandre.soeiro@bol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Mucio Tavares, MD | Unidade ClÃnica de Emergência | Principal Investigator |
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| adjust dobutamine according to the attending physician | Procedure | adjust dobutamine dose |
|
serum analysis |
| 24 hours |
| heart rate | physical evaluation | 24 hours |
| creatinine levels | serum analysis | 24 hours |
| urea levels | serum analysis | 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 |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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