Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
— IABCSOfficial title:
Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Heart Institute | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Duration of mechanical ventilation | Number of days during mechanical ventilation. | 30 days | No |
Secondary | IABP complications | Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding. | 30 days | Yes |
Secondary | Use of vasoactive agents | Number of days and dose of inotropes and vasopressors. | 30 days | No |
Secondary | Evaluation of hemodynamic data | Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output. | 48 hours | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 30-day mortality | Death during hospital stay or death after hospital discharge until 30 days following the procedure | 30 days | Yes |
Secondary | 60-days mortality | Death until 60 days following the procedure | 60 days | Yes |
Secondary | 1-year mortality | Death until 1 year following the procedure | 1 year | No |
Secondary | Costs | Comparison of overall costs between groups. | 30 days | No |
Secondary | Acute Kidney Injury | Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification. | 30 days | Yes |
Secondary | Cardiovascular complications | Arrhythmias or myocardial ischemia within 30 days after randomization | 30 days | Yes |
Secondary | Infectious complications | New infection or septic shock within 30 days after randomization | 30 days | Yes |
Secondary | Delirium | Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization | 30 days | Yes |
Secondary | Bleeding | Blood losses exceeding 100-300 mL per hour following ICU admission | 24 hours | Yes |
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