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
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- cardiac output
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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
研究组 & 干预措施
Liberal strategy
Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the attending physician
干预措施: adjust dobutamine according to the attending physician (Procedure)
ejection volume index
Initiate dobutamine at 5 mcg/kg/min and adjust dobutamine according to the ejection volume index
干预措施: adjust dobutamine according to the ejection volume index (Procedure)
结局指标
主要结局
cardiac output
时间窗: 24 hours
echocardiography echocardiography
systolic and diastolic blood pressure
时间窗: 24 hours
physical evaluation
bicarbonate levels
时间窗: 24 hours
serum analysis
systolic volume
时间窗: 24 hours
echocardiography
central venous oxygen saturation levels
时间窗: 24 hours
serum analysis
heart rate
时间窗: 24 hours
physical evaluation
base excess levels
时间窗: 24 hours
serum analysis
arterial lactate levels
时间窗: 24 hours
serum analysis
creatinine levels
时间窗: 24 hours
serum analysis
urinary output
时间窗: 24 hours
urine analysis
urea levels
时间窗: 24 hours
serum analysis
BNP levels
时间窗: 24 hours
plasma analysis
troponin levels
时间窗: 24 hours
serum analysis
次要结局
- 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)