Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery (IABCS)

University of Sao Paulo

Status: Unknown

Conditions: Postoperative; Dysfunction Following Cardiac Surgery

Treatments: Device: Intra-aortic balloon pump.

Study type: Interventional

Funder types: Other

Identifiers

NCT02143544

Heart Institute

Details and patient eligibility

About

The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Preoperative intra-aortic balloon pump.

Active Comparator group

Description:

Intervention: Preoperative placement of the intra-aortic balloon pump.

Treatment:

Device: Intra-aortic balloon pump.

Control

No Intervention group

Description:

No preoperative placement of the intra-aortic balloon pump.