Postoperative; Dysfunction Following Cardiac Surgery
Conditions
Keywords
Intra-aortic balloon counterpulsation, Cardiac surgery, High-risk patients
Brief summary
The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.
Detailed description
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.
Interventions
DEVICEIntra-aortic balloon pump.
Preoperative placement of the intra-aortic balloon pump.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age equal to or higher than 18 years old * EuroSCORE equal to or higher than 6 or ejection fraction equal to or lower than 40% * Written informed consent
Exclusion criteria
* Cardiogenic shock * Acute myocardial infarction (AMI) \< 48 hours * Mechanical complications of AMI * Peripheral vascular disease (aorta, iliac or femoral) * Severe aortic regurgitation * Neoplasm * Pregnancy * Tachyarrhythmia * Procedures of the aorta * Coagulopathy * Thrombocytopenia * Cardiac transplantation, congenital heart disease or endocarditis * Refusal to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure) | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | 30 days | Number of days during mechanical ventilation. |
| IABP complications | 30 days | Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding. |
| Use of vasoactive agents | 30 days | Number of days and dose of inotropes and vasopressors. |
| Evaluation of hemodynamic data | 48 hours | Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output. |
| Levels of biomarkers | 7 days | 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) |
| Echocardiographic parameters | 7 days | 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. |
| 30-day mortality | 30 days | Death during hospital stay or death after hospital discharge until 30 days following the procedure |
| Acute Kidney Injury | 30 days | Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification. |
| 1-year mortality | 1 year | Death until 1 year following the procedure |
| Costs | 30 days | Comparison of overall costs between groups. |
| Cardiovascular complications | 30 days | Arrhythmias or myocardial ischemia within 30 days after randomization |
| Infectious complications | 30 days | New infection or septic shock within 30 days after randomization |
| Delirium | 30 days | Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization |
| Bleeding | 24 hours | Blood losses exceeding 100-300 mL per hour following ICU admission |
| 60-days mortality | 60 days | Death until 60 days following the procedure |
Countries
Brazil
Contacts
Primary ContactLudhmila A Hajjar, PhD
Backup ContactGraziela Ferreira, Dr
Outcome results
None listed