Cardiogenic Shock, Heart Failure
Conditions
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.
Interventions
PROCEDUREadjust dobutamine according to the ejection volume index
adjust dobutamine dose
PROCEDUREadjust dobutamine according to the attending physician
adjust dobutamine dose
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urea levels | 24 hours | serum analysis |
| systolic and diastolic blood pressure | 24 hours | physical evaluation |
| cardiac output | 24 hours | echocardiography echocardiography |
| systolic volume | 24 hours | echocardiography |
| urinary output | 24 hours | urine analysis |
| arterial lactate levels | 24 hours | serum analysis |
| central venous oxygen saturation levels | 24 hours | serum analysis |
| BNP levels | 24 hours | plasma analysis |
| troponin levels | 24 hours | serum analysis |
| heart rate | 24 hours | physical evaluation |
| creatinine levels | 24 hours | serum analysis |
| base excess levels | 24 hours | serum analysis |
| bicarbonate levels | 24 hours | serum analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| need for orotracheal intubation | 24 hours | — |
| need for vasopressor or other inotropic association | 24 hours | hipotension |
| need for mechanical circulatory assistance | 24 hours | — |
| lowering of consciousness level | 24 hours | glasgow \< 14 |
| cardiorespiratory arrest | 24 hours | — |
| worsening of renal function | 24 hours | increase 0.5 mg / dl in relation to admission creatinine |
| death | 24 hours | — |
| failure of dobutamine weaning up | 7 days | — |
| hospitalization time | 30 days | — |
| occurrence of sustained ventricular arrhythmia | 24 hours | electrocardiography |
Contacts
Primary ContactAlexandre Soeiro, MD
Outcome results
None listed