Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial

Conditions
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Postoperative; Dysfunction Following Cardiac Surgery

Intervention / Treatment
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* Device: Intra-aortic balloon pump.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preoperative intra-aortic balloon pump.<br>Intervention: Preoperative placement of the intra-aortic balloon pump. | Device: Intra-aortic balloon pump.<br>* Preoperative placement of the intra-aortic balloon pump.<br>|
| No Intervention: Control<br>No preoperative placement of the intra-aortic balloon pump. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | Number of days during mechanical ventilation. | 30 days | 
| IABP complications | Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding. | 30 days | 
| Use of vasoactive agents | Number of days and dose of inotropes and vasopressors. | 30 days | 
| Evaluation of hemodynamic data | Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output. | 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) | 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. | 7 days | 
| 30-day mortality | Death during hospital stay or death after hospital discharge until 30 days following the procedure | 30 days | 
| 60-days mortality | Death until 60 days following the procedure | 60 days | 
| 1-year mortality | Death until 1 year following the procedure | 1 year | 
| Costs | Comparison of overall costs between groups. | 30 days | 
| Acute Kidney Injury | Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification. | 30 days | 
| Cardiovascular complications | Arrhythmias or myocardial ischemia within 30 days after randomization | 30 days | 
| Infectious complications | New infection or septic shock within 30 days after randomization | 30 days | 
| Delirium | Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization | 30 days | 
| Bleeding | Blood losses exceeding 100-300 mL per hour following ICU admission | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra-aortic balloon counterpulsation, Cardiac surgery, High-risk patients