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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative; Dysfunction Following Cardiac Surgery
• Intervention / Treatment: Device: Intra-aortic balloon pump.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ludhmila A Hajjar, PhD; Phone Number: 11-26625232; Email: ludhmila@usp.br
• Study Contact Backup: Name: Graziela Ferreira, Dr; Phone Number: 11-26615367; Email: gsrf@uol.com.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403000
      • Recruiting
      • Heart Institute
      • Contact: Graziela Ferreira, Dr; Phone Number: 11-26615367; Email: gsrf@uol.com.br
      • Contact: Ludhmila A Hajjar, PhD; Phone Number: 11-26615232; Email: ludhmila@usp.br
      • Principal Investigator: Ludhmila A Hajjar, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preoperative intra-aortic balloon pump.; Intervention: Preoperative placement of the intra-aortic balloon pump.	Device: Intra-aortic balloon pump.; Preoperative placement of the intra-aortic balloon pump.
No Intervention: Control; No preoperative placement of the intra-aortic balloon pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	Number of days during mechanical ventilation.	30 days
IABP complications	Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding.	30 days
Use of vasoactive agents	Number of days and dose of inotropes and vasopressors.	30 days
Evaluation of hemodynamic data	Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output.	48 hours
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
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
30-day mortality	Death during hospital stay or death after hospital discharge until 30 days following the procedure	30 days
60-days mortality	Death until 60 days following the procedure	60 days
1-year mortality	Death until 1 year following the procedure	1 year
Costs	Comparison of overall costs between groups.	30 days
Acute Kidney Injury	Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification.	30 days
Cardiovascular complications	Arrhythmias or myocardial ischemia within 30 days after randomization	30 days
Infectious complications	New infection or septic shock within 30 days after randomization	30 days
Delirium	Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization	30 days
Bleeding	Blood losses exceeding 100-300 mL per hour following ICU admission	24 hours

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 18, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac surgery; High-risk patients; Intra-aortic balloon counterpulsation
• Other Study ID Numbers: Heart Institute