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Completed

NCT Number: NCT03857906

Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery

Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.

Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.

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Key information

Conditions

Ischemic Cardiomyopathy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).

Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p <0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients greater than 18 years
  • Scheduled for coronary artery bypass graft (CABG) surgery were eligible
  • Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (>50%)
  • Written informed consent provided

Exclusion criteria

  • Prior cardiogenic shock,
  • Acute myocardial infarction (AMI) less than 48 hours prior to enrollment
  • Previous IABP use
  • AMI mechanical complications
  • Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)
  • Tachyarrhythmia
  • Other aortic procedures
  • Other non-CABG surgical procedures
  • Massive pulmonary embolism
  • Older than 90 years of age
  • Any coagulopathy
  • Severe concomitant disease associated with a life expectancy of less than 6 months.

Treatment and study plan

Intra-Aortic Ballon Pump insertion

Device

The IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG

Primary outcomes

  1. 30-Day All-Cause Mortality

    Time frame: 30 days

    30-Day Mortality

  2. 30-Day Postoperative Myocardial Infarction

    Time frame: 30 days

    Based on the third universal definition on MI criteria

Secondary outcomes

  1. 30-day occurrence rate of PCI

    Time frame: 30 days

    30-day occurrence rate of emergent percutaneous coronary intervention

  2. Requirement of mechanical ventilation

    Time frame: 30 days

    Requirement of mechanical ventilation for longer than 24 hours

  3. acute kidney injury

    Time frame: 30 days

    AKIN classification

  4. Need for renal replacement therapy

    Time frame: 30 days

    Need for RRT (hemodialysis, peritoneal)

  5. ICU length of stay

    Time frame: 30 days

    ICU and in-hospital length of stay

  6. Postoperative use of inotropes and vasopressors

    Time frame: 30 days

    Postoperative use of inotropes and vasopressors

Sponsors and collaborators

Lead sponsor

CMN "20 de Noviembre"

Other

Collaborators

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Registry information

Official study title

Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery: A Single-Centre Study

Acronym: IABP-HR

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Feb 28, 2019
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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