The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.
High-risk patients undergoing cardiac surgery are at high risk for myocardial ischemia, arrhythmia, cardiogenic shock and other clinical complications. Different therapeutic options are available to support these patients in the perioperative period including inotropes, vasopressors, and vasodilators, and also assist devices such as intra-aortic balloon pump (IABP) and others. IABP increases myocardial oxygen supply by increasing diastolic coronary perfusion pressure and decreases myocardial oxygen demand by reducing left ventricular afterload. Additionally, IABP can also improve cardiac output and systemic perfusion. The hypothesis of this randomized and controlled trial is that the placement of IABP immediately before the cardiac surgery reduces clinical complications in high-risk patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Preoperative placement of the intra-aortic balloon pump.
Heart Institute
São Paulo, São Paulo, Brazil
RECRUITINGComposite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
Composite outcome of 30-day mortality or incidence of patients presenting a major complication according to modified Society of Thoracic Surgeons (STS): mechanical ventilation \> 24 hours, deep sternal wound infection/mediastinitis, surgical reexploration, stroke, cardiogenic shock and acute renal failure.
Time frame: 30 days
Duration of mechanical ventilation
Number of days during mechanical ventilation.
Time frame: 30 days
IABP complications
Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding.
Time frame: 30 days
Use of vasoactive agents
Number of days and dose of inotropes and vasopressors.
Time frame: 30 days
Evaluation of hemodynamic data
Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output.
Time frame: 48 hours
Levels of biomarkers
Comparison of the following biomarker levels between groups: pro-BNP (Brain natriuretic peptide), troponin I and Neutrophil gelatinase-associated lipocalin (NGAL), Heart-type Fatty Acid Binding Protein (H-FABP)
Time frame: 7 days
Echocardiographic parameters
Comparison of the following echocardiographic parameters between groups: left ventricular ejection fraction, cardiac output, left ventricular diastolic diameter, left ventricular systolic diameter and wall motion abnormalities.
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Time frame: 7 days
30-day mortality
Death during hospital stay or death after hospital discharge until 30 days following the procedure
Time frame: 30 days
60-days mortality
Death until 60 days following the procedure
Time frame: 60 days
1-year mortality
Death until 1 year following the procedure
Time frame: 1 year
Costs
Comparison of overall costs between groups.
Time frame: 30 days
Acute Kidney Injury
Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification.
Time frame: 30 days
Cardiovascular complications
Arrhythmias or myocardial ischemia within 30 days after randomization
Time frame: 30 days
Infectious complications
New infection or septic shock within 30 days after randomization
Time frame: 30 days
Delirium
Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization
Time frame: 30 days
Bleeding
Blood losses exceeding 100-300 mL per hour following ICU admission
Time frame: 24 hours