Heart Failure Clinical Trial
— IABP-HROfficial title:
Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery: A Single-Centre Study
NCT number | NCT03857906 |
Other study ID # | .2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 21, 2014 |
Est. completion date | January 19, 2019 |
Verified date | March 2019 |
Source | CMN "20 de Noviembre" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 129 |
Est. completion date | January 19, 2019 |
Est. primary completion date | February 21, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
CMN "20 de Noviembre" | Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-Day All-Cause Mortality | 30-Day Mortality | 30 days | |
Primary | 30-Day Postoperative Myocardial Infarction | Based on the third universal definition on MI criteria | 30 days | |
Secondary | 30-day occurrence rate of PCI | 30-day occurrence rate of emergent percutaneous coronary intervention | 30 days | |
Secondary | Requirement of mechanical ventilation | Requirement of mechanical ventilation for longer than 24 hours | 30 days | |
Secondary | acute kidney injury | AKIN classification | 30 days | |
Secondary | Need for renal replacement therapy | Need for RRT (hemodialysis, peritoneal) | 30 days | |
Secondary | ICU length of stay | ICU and in-hospital length of stay | 30 days | |
Secondary | Postoperative use of inotropes and vasopressors | Postoperative use of inotropes and vasopressors | 30 days |
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