Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Postoperative; Dysfunction Following Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative intra-aortic balloon pump.

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

Group Type ACTIVE_COMPARATOR

Intra-aortic balloon pump.

Intervention Type DEVICE

Preoperative placement of the intra-aortic balloon pump.

Control

No preoperative placement of the intra-aortic balloon pump.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intra-aortic balloon pump.

Preoperative placement of the intra-aortic balloon pump.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No