Clinical trial NCT02143544: Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery
Official title: Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Keywords: Intra-aortic balloon counterpulsation
Cardiac surgery
High-risk patients
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
timeFrame: 30 days
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 30 days
measure: IABP complications
timeFrame: 30 days
measure: Use of vasoactive agents
timeFrame: 30 days
measure: Evaluation of hemodynamic data
timeFrame: 48 hours
measure: Levels of biomarkers
timeFrame: 7 days
measure: Echocardiographic parameters
timeFrame: 7 days
measure: 30-day mortality
timeFrame: 30 days
measure: 60-days mortality
timeFrame: 60 days
measure: 1-year mortality
timeFrame: 1 year
measure: Costs
timeFrame: 30 days
measure: Acute Kidney Injury
timeFrame: 30 days
measure: Cardiovascular complications
timeFrame: 30 days
measure: Infectious complications
timeFrame: 30 days
measure: Delirium
timeFrame: 30 days
measure: Bleeding
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute
state: SP
Study officials:
References:
citation: Caldas JR, Panerai RB, Bor-Seng-Shu E, Ferreira GSR, Camara L, Passos RH, Salinet AM, Azevedo DS, de-Lima-Oliveira M, Galas FRBG, Fukushima JT, Nogueira R, Taccone FS, Landoni G, Almeida JP, Robinson TG, Hajjar LA. Intra-aortic balloon pump does not influence cerebral hemodynamics and neurological outcomes in high-risk cardiac patients undergoing cardiac surgery: an analysis of the IABCS trial. Ann Intensive Care. 2019 Nov 27;9(1):130. doi: 10.1186/s13613-019-0602-z.
citation: Caldas JR, Panerai RB, Bor-Seng-Shu E, Ferreira GSR, Camara L, Passos RH, de-Lima-Oliveira M, Galas FRBG, Almeida JP, Nogueira RC, Mian N, Gaiotto FA, Robinson TG, Hajjar LA. Dynamic cerebral autoregulation: A marker of post-operative delirium? Clin Neurophysiol. 2019 Jan;130(1):101-108. doi: 10.1016/j.clinph.2018.11.008. Epub 2018 Nov 22.