Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery

Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial

— IABCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02143544
• Other study ID #: Heart Institute
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2014
• Last updated: February 3, 2016
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: University of Sao Paulo
• Contact: Ludhmila A Hajjar, PhD
• Phone: 11-26625232
• Email: ludhmila[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative; Dysfunction Following Cardiac Surgery

Intervention

Device:
• Intra-aortic balloon pump.
Preoperative placement of the intra-aortic balloon pump.

Locations

Country	Name	City	State
Brazil	Heart Institute	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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